Product Code: LFL
FDA unclassified
Instrument, Ultrasonic Surgical
Unknown
An ultrasonic surgical instrument is a device that uses high-frequency ultrasonic vibration to cut tissue and coagulate blood vessels simultaneously during surgical procedures, reducing thermal damage to surrounding tissue compared to conventional electrosurgical methods. This device is currently unclassified by the FDA, meaning a formal risk classification has not yet been established. It carries product code LFL and no regulation number or medical specialty has been assigned. No special flags apply to this device.
510(k)s
156
FEI Numbers
138
Registration Numbers
138
Unique Applicants
84
Years Active
45
Basic Information
- Product Code
- LFL
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
Unclassified Reason
1
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 156 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K242894 | SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile Ultrasonic Surgery Advanced Dissector (SASD45) | Jun 18, 2025 | Substantially Equivalent | Shanghai Saints Sages Surgical Co., Ltd. |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | Mar 24, 2025 | Substantially Equivalent | Stryker Instruments |
| K241700 | Tenex 2nd Generation System | Nov 18, 2024 | Substantially Equivalent | Trice Medical, Inc. |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator System | Jul 11, 2024 | Substantially Equivalent | Integra LifeSciences Corporation |
| K233036 | Ultrasonic Surgical System | Jun 18, 2024 | Substantially Equivalent | Hunan Handlike Minimally Invasive Surgery Co., Ltd. |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator System | Jul 11, 2023 | Substantially Equivalent | Integra Lifesciences Corporation |
| K231117 | neXus Ultrasonic Surgical Aspirator System | Jun 23, 2023 | Substantially Equivalent | Misonix, LLC, a Bioventus Company |
| K221790 | HARMONIC 700 Shears | Feb 28, 2023 | Substantially Equivalent | Ethicon Endo-Surgery, LLC |
| K223770 | Sonopet 1Q 3 7cm 1Q Large | Feb 16, 2023 | Substantially Equivalent | Stryker Corporation |
| K221102 | LOTUS Series 4 Enhanced Shears, LOTUS Series 5 | Dec 15, 2022 | Substantially Equivalent | SRA Developments Ltd |
| K210567 | Ultrasonic Surgical System | Sep 30, 2022 | Substantially Equivalent | Miconvey Technologies Co., Ltd. |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator System | Aug 22, 2022 | Substantially Equivalent | Integra Lifesciences Corporation |
| K221235 | neXus Ultrasonic Surgical Aspirator System | Jul 28, 2022 | Substantially Equivalent | Misonix Inc. |
| K212614 | Ultrasonic Scalpel System | Jul 18, 2022 | Substantially Equivalent | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator System | Jul 15, 2022 | Substantially Equivalent | Integra LifeSciences Corporation |
| K212049 | Oclet TDS 1000 | Mar 08, 2022 | Substantially Equivalent | TendoNova Corporation |
| K213824 | Sonopet iQ Ultrasonic Aspirator System | Feb 03, 2022 | Substantially Equivalent | Stryker Corporation |
| K212060 | neXus Ultrasonic Surgical Aspirator System | Dec 13, 2021 | Substantially Equivalent | Misonix Inc. |
| K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device | Nov 15, 2021 | Substantially Equivalent | Covidien, LLC |
| K212750 | Ultrasonic Surgical Aspirator System, Model: XD880B | Sep 27, 2021 | Substantially Equivalent | SMTP Technology Co., Ltd. |
| K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Aug 04, 2021 | Substantially Equivalent | Olympus Medical Systems Corporation |
| K211273 | Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray | May 21, 2021 | Substantially Equivalent | Ethicon Endo-Surgery, LLC |
| K202299 | Ultrasonic Surgical Aspirator System | May 21, 2021 | Substantially Equivalent | SMTP Technology Co., Ltd |
| K200427 | Sonicision Cordless Ultrasonic Dissector | Jul 10, 2020 | Substantially Equivalent | Covidien, llc |
| K200774 | CUSA Clarity Ultrasonic Surgical Aspirator System | Jun 23, 2020 | Substantially Equivalent | Integra LifeSciences Corporation |
| K192963 | Kogent Torus Ultrasonic Aspirator | Jun 19, 2020 | Substantially Equivalent | Katalyst Surgical, LLC |
| K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length | Feb 28, 2020 | Substantially Equivalent | Ethicon Endo-Surgery, LLC |
| K190281 | Ultrasonic Surgical System | Oct 31, 2019 | Substantially Equivalent | MediSonic Technology Co |
| K190160 | neXus Ultrasonic Surgical Aspirator System | May 30, 2019 | Substantially Equivalent | Misonix, Inc. |
| K190070 | Sonopet iQ Ultrasonic Aspirator System | Apr 11, 2019 | Substantially Equivalent | Stryker Corporation |
| K190180 | CUSA Clarity Ultrasonic Surgical Aspirator System | Apr 01, 2019 | Substantially Equivalent | Integra LifeSciences Corporation |
| K182809 | CUSA Clarity Ultrasonic Surgical Aspirator System | Dec 07, 2018 | Substantially Equivalent | Integra LifeSciences Corporation |
| K181367 | Tenex Health TX System with the TXP MicroTip | Aug 28, 2018 | Substantially Equivalent | Tenex Health, Inc. |
| K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide | Mar 26, 2018 | Substantially Equivalent | Covidien, llc |
| K172691 | Ultrasonic Generator | Oct 04, 2017 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORP. |
| K172595 | CUSA Excel+ Ultrasonic Surgical Aspirator System | Sep 28, 2017 | Substantially Equivalent | Integra LifeSciences Corporation |
| K161882 | CUSA Clarity Ultrasonic Surgical Aspirator System | Oct 14, 2016 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K160752 | HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length | Jun 29, 2016 | Substantially Equivalent | ETHICON ENDO-SUREGERY, LLC |
| K153371 | Sonicision Cordless Ultrasonic Dissection Device | Mar 28, 2016 | Substantially Equivalent | COVIDIEN LLC |
| K151136 | HARMONIC HOOK | Mar 04, 2016 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K153299 | Tenex Health TX System | Mar 03, 2016 | Substantially Equivalent | TENEX HEALTH, INC. |
| K150682 | CUSA Excel+ | Dec 18, 2015 | Substantially Equivalent | INTEGRA LIFESCIENCES CORP. |
| K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | Jul 17, 2015 | Substantially Equivalent | SRA DEVELOPMENTS, LTD. |
| K151340 | HARMONIC Focus Long Shears + Adaptive Tissue Technology | Jul 10, 2015 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K150271 | Prime Adaptive Ultrasonic Scalpel System | May 29, 2015 | Substantially Equivalent | ENDOPRIME, INC. |
| K141674 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Nov 06, 2014 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K141668 | CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Nov 06, 2014 | Substantially Equivalent | INTEGRA LIFESCIENCES CORPORATION |
| K141371 | SONICISION CORDLESS ULTRASONIC DISSECTOR | Aug 07, 2014 | Substantially Equivalent | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO H |
| K132522 | HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE | Dec 16, 2013 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K133314 | HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY | Dec 03, 2013 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K132512 | HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE | Oct 24, 2013 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K132612 | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE | Oct 17, 2013 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K123640 | TX1 TISSUE REMOVAL SYSTEM | Mar 20, 2013 | Substantially Equivalent | TENEX HEALTH |
| K121550 | HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY | Aug 22, 2012 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K120729 | HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 | May 17, 2012 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K113570 | INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP | Feb 22, 2012 | Substantially Equivalent | INTEGRA BURLINGTON MA, INC. |
| K111741 | INTEGRA(TM) CUSA NXT(TM) BONE TIPS | Aug 23, 2011 | Substantially Equivalent | INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI |
| K102258 | CUSA NXT EXTENDED LENGTH TIP | Jun 10, 2011 | Substantially Equivalent | INTEGRA RADIONICS, INC. |
| K101797 | SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T | Feb 24, 2011 | Substantially Equivalent | COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO |
| K101561 | TX1 TISSUE REMOVAL SYSTEM | Aug 27, 2010 | Substantially Equivalent | AMERICAN OPTISURGICAL, INC. |
| K100597 | HARMONIC FOCUS SHEARS | Apr 07, 2010 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K090864 | CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | May 08, 2009 | Substantially Equivalent | INTEGRA RADIONICS, INC. |
| K081459 | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM | Aug 13, 2008 | Substantially Equivalent | INTEGRA RADIONICS, INC. |
| K072904 | SONOCA 180/195 WOUND CARE SYSTEM | May 21, 2008 | Substantially Equivalent | SOERING GMBH |
| K072203 | HARMONIC 10CM COMBINATION HOOK BLADE | Sep 25, 2007 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K071669 | INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP | Aug 17, 2007 | Substantially Equivalent | INTEGRA RADIONICS, INC. |
| K070360 | KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 | Aug 07, 2007 | Substantially Equivalent | KIRWAN SURGICAL PRODUCTS, INC. |
| K070313 | MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | May 11, 2007 | Substantially Equivalent | MISONIX, INC. |
| K063531 | SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM | Feb 22, 2007 | Substantially Equivalent | SRA DEVELOPMENTS, LTD. |
| K063192 | HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP | Jan 30, 2007 | Substantially Equivalent | ETHICON ENDO-SURGERY, LLC |
| K062544 | AR1000 ULTRASONIC WOUND THERAPY SYSTEM | Jan 03, 2007 | Substantially Equivalent | AROBELLA MEDICAL, LLC |
| K062471 | ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF | Oct 26, 2006 | Substantially Equivalent | MISONIX, INC. |
| K062000 | HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH | Sep 25, 2006 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K060245 | HARMONIC SCALPEL BLADES AND SHEARS | Apr 07, 2006 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K053056 | HARMONIC SCALPEL BLADES AND SHEARS | Jan 19, 2006 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K051947 | RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE | Aug 22, 2005 | Substantially Equivalent | RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
| K050776 | AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Jun 06, 2005 | Substantially Equivalent | MISONIX, INC. |
| K050885 | OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG | Jun 03, 2005 | Substantially Equivalent | OLYMPUS MEDICAL SYSTEMS CORPORATION |
| K051036 | HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P | Jun 02, 2005 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K042160 | SONOSURG TROCAR | Jan 25, 2005 | Substantially Equivalent | AOMORI OLYMPUS CO., LTD. |
| K042777 | HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P | Dec 01, 2004 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K042277 | SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM | Sep 29, 2004 | Substantially Equivalent | INTEGRA NEUROSCIENCES, LTD. |
| K041566 | SONOSURG ULTRASONIC SURGICAL SYSTEM | Sep 08, 2004 | Substantially Equivalent | AOMORI OLYMPUS CO., LTD. |
| K032424 | LOTUS | Dec 16, 2003 | Substantially Equivalent | SRA DEVELOPMENTS, LTD. |
| K032690 | MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Dec 09, 2003 | Substantially Equivalent | MISONIX, INC. |
| K032066 | SONOSURG SYSTEM | Oct 03, 2003 | Substantially Equivalent | THE OLYMPUS OPTICAL CO. |
| K031523 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Oct 01, 2003 | Substantially Equivalent | AOMORI OLYMPUS CO., LTD. |
| K031305 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Sep 23, 2003 | Substantially Equivalent | OLYMPUS OPTICAL CO., LTD. |
| K031710 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Aug 29, 2003 | Substantially Equivalent | AOMORI OLYMPUS CO., LTD. |
| K021962 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Feb 12, 2003 | Substantially Equivalent | THE OLYMPUS OPTICAL CO. |
| K021989 | SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 | Sep 13, 2002 | Substantially Equivalent | INTEGRA NEUROSCIENCES |
| K021929 | AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM | Sep 10, 2002 | Substantially Equivalent | AXYA MEDICAL, INC. |
| K020220 | ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE | Aug 23, 2002 | Substantially Equivalent | SYNERGETICS, INC. |
| K012753 | SORING GMBH SONOCA 180/190 | Nov 13, 2001 | Substantially Equivalent | SORING GMBH MEDIZINTECHNIK |
| K012176 | ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 | Oct 01, 2001 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K012028 | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 | Jul 27, 2001 | Substantially Equivalent | MISONIX, INC. |
| K010898 | ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145 | May 31, 2001 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K010637 | SONOTOME ULTRASONIC ASPIRATOR TIPS | Apr 20, 2001 | Substantially Equivalent | SYNERGETICS, INC. |
| K010309 | SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR | Apr 18, 2001 | Substantially Equivalent | MUTOH AMERICA CO., LTD. |
| K003824 | OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI | Mar 08, 2001 | Substantially Equivalent | OMNISONICS MEDICAL TECHNOLOGIES |
| K002906 | ULTRACISION HARMONIC SCALPEL SYSTEM, MODELS GEN01, GEN02, GEN03, HP052, HP053, HSA07 | Dec 15, 2000 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K000927 | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 | Oct 10, 2000 | Substantially Equivalent | MISONIX, INC. |
| K000095 | OLYMPUS SONOSURG TROCAR XT3900 SYSTEM | Sep 26, 2000 | Substantially Equivalent | THE OLYMPUS OPTICAL CO. |
| K994280 | ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105 | Mar 17, 2000 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K993868 | THE SOUNDVASER DISSECTION SYSTEM | Dec 21, 1999 | Substantially Equivalent | SOUND SURGICAL TECHNOLOGIES LLC. |
| K993628 | OMNISONICS ULTRASONIC PROBES | Dec 15, 1999 | Substantially Equivalent | OMNISONICS MEDICAL TECHNOLOGIES |
| K993054 | ULTRACISION HARMONIC SCALPEL COAGULATING SHEARS, MODELS LCS-C5, LCS-C1, CS-23C, CS-231, CS-14C, CS-141 | Dec 09, 1999 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K991791 | SOUND VASER SYSTEM | Aug 12, 1999 | Substantially Equivalent | SOUND SURGICAL TECHNOLOGIES LLC. |
| K990572 | SONOTOME | May 21, 1999 | Substantially Equivalent | SONOKINETICS, INC. |
| K990430 | ULTRACISION HARMONIC SCALPEL HAND PIECE | Mar 12, 1999 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K983199 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL | Dec 14, 1998 | Substantially Equivalent | FIBRA SONICS, INC. |
| K983065 | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM | Dec 01, 1998 | Substantially Equivalent | MENTOR CORP. |
| K980895 | ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR | Nov 06, 1998 | Substantially Equivalent | CALIFORNIA INSTITUTE OF TISSUE ENG. & INSTRUMENTI |
| K983316 | ULTRACISION 5MM INSTRUMENTS | Oct 21, 1998 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K980930 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA | Sep 22, 1998 | Substantially Equivalent | FIBRA SONICS, INC. |
| K982841 | MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4 | Sep 04, 1998 | Substantially Equivalent | MISONIX, INC. |
| K981262 | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Jul 06, 1998 | Substantially Equivalent | VALLEYLAB, INC. |
| K972114 | OLYMPUS SONOSURG SYSTEM | May 18, 1998 | Substantially Equivalent | THE OLYMPUS OPTICAL CO. |
| K980099 | ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5)) | Apr 09, 1998 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K972148 | B.U.S. ENDOTRON | Dec 10, 1997 | Substantially Equivalent | MEDICAMAT S.A. |
| K971580 | UAS ULTRASONIC ASPIRATOR SYSTEM | Dec 09, 1997 | Substantially Equivalent | WELLS JOHNSON CO. |
| K971609 | SCULPTURE | Aug 14, 1997 | Substantially Equivalent | SERVIZI MEDICO ESTETICI ITALINAI SRL. |
| K971533 | VIBRA-SURGE SYSTEM MODEL VS2120 | Jul 25, 1997 | Substantially Equivalent | SONICS & MATERIALS, INC. |
| K970471 | MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) | Jul 17, 1997 | Substantially Equivalent | MENTOR CORP. |
| K971302 | ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE | Jul 07, 1997 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K971861 | ULTRASONIC HAND INSTRUMENTS | Jul 01, 1997 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K964742 | RONIX II ROTARY ULTRASONIC SURGICAL SYSTEM | Apr 22, 1997 | Substantially Equivalent | AZIZ Y. ANIS, M.D. |
| K964601 | CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY | Jan 16, 1997 | Substantially Equivalent | VALLEYLAB, INC. |
| K962584 | ULTRACISION 5MM HARD SHEATH LAPAROSONIC BLADE | Nov 04, 1996 | Substantially Equivalent | ETHICON ENDO-SURGERY, INC. |
| K962525 | ULTRA-SAFE ULTRASONIC ASPIRATOR SYSTEM | Sep 19, 1996 | Substantially Equivalent | MORWEL CORP. |
| K960374 | ULTRACUT 2000 | Jun 28, 1996 | Substantially Equivalent | ULTRALASE TECHNOLOGIES, INC. |
| K960040 | SHARPLAN ULTRA LAPAROSCOPIC HANDPIECE | Apr 29, 1996 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K934628 | CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS | Jul 11, 1995 | Substantially Equivalent | VALLEYLAB, INC. |
| K950945 | COOPER LASER SONICS CUSA MODEL 200 | Apr 10, 1995 | Substantially Equivalent | VALLEYLAB, INC. |
| K942095 | SONOCA III | Nov 09, 1994 | Substantially Equivalent | HOLL MEDITRONICS, INC. |
| K931902 | CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS. | Sep 16, 1994 | Substantially Equivalent | VALLEYLAB, INC. |
| K933559 | ALLIGER ULTRASONIC SURGICAL SYSTEM | Oct 15, 1993 | Substantially Equivalent | MEDSONIC, INC. |
| K933239 | CV720-727-000, MICROTIP AND FLUE PAK | Oct 12, 1993 | Substantially Equivalent | VALLEYLAB, INC. |
| K932094 | BOVIE ULTRASONIC SURGICAL ASPIRATOR | Jul 21, 1993 | Substantially Equivalent | MDT CORP., INC. |
| K921251 | CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR | Jun 12, 1992 | Substantially Equivalent | VALLEYLAB, INC. |
| K910696 | CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR | Jun 11, 1991 | Substantially Equivalent | VALLEYLAB, INC. |
| K904010 | SURGICAL ASPIRATOR KIT | Nov 21, 1990 | Substantially Equivalent | SURGEON SURGICAL INSTRUMENTATION, INC. |
| K901974 | SELECTOR ULTRASONIC SURGICAL ASPIRATOR | Sep 05, 1990 | Substantially Equivalent | SPEMBLY MEDICAL LTD. |
| K901737 | SONOCA II ULTRASONIC SURGICAL DEVICE | Jul 03, 1990 | Substantially Equivalent | HOLL MEDITRONICS, INC. |
| K894600 | CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR | Jan 19, 1990 | Substantially Equivalent | VALLEYLAB, INC. |
| K893926 | SONOCA ULTRASONIC SURGICAL SYSTEM | Nov 14, 1989 | Substantially Equivalent | HOLL MEDITRONICS, INC. |
| K883091 | SHARPLAN 4300 & 4310 ULTRASONIC SURGICAL APIRATORS | Oct 14, 1988 | Substantially Equivalent | SHARPLAN LASERS, INC. |
| K880815 | DX101-T ULTRASONIC SURGICAL SYSTEM | Apr 13, 1988 | Substantially Equivalent | NIIC U.S.A., INC. |
| K880814 | DX101 ULTRASONIC SURGICAL SYSTEM | Apr 13, 1988 | Substantially Equivalent | NIIC U.S.A., INC. |
| K880166 | BOVIE ULTRASONIC SURGICAL ASPIRATOR, MODEL ME2000 | Feb 18, 1988 | Substantially Equivalent | CLINICAL TECHNOLOGY CORP. |
| K864983 | CUSA SYSTEM 200 MACRO-DISSECTOR | Jun 23, 1987 | Substantially Equivalent | COOPER LASERSONICS, INC. |
| K852539 | SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP | Jul 23, 1985 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K851203 | R PAK | Jul 23, 1985 | Substantially Equivalent | COOPERVISION, INC. |
| K830753 | NEEDLE GUIDE MODEL 21285A | Jun 16, 1983 | Substantially Equivalent | HEWLETT-PACKARD CO. |
| K821820 | MCSC6PS MEDICAL COMPONENTS | Jul 13, 1982 | Substantially Equivalent | MEDICAL COMPONENTS, INC. |
| K801623 | CAVITRON ULTRASONIC SURG. ASPIR. CUSA | Nov 18, 1980 | Substantially Equivalent | CAVITRON CORP. |
FEI Numbers
This FDA classification entry is associated with 138 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 138 registration numbers. Click on an entry to view related FDA registrations.