Product Code: EOB FDA class 2 21 CFR 874.4760

Nasopharyngoscope (Flexible Or Rigid)

Ear, Nose, Throat

The nasopharyngoscope is a flexible or rigid endoscopic instrument used to directly visualize the nasopharynx and assess conditions such as polyps, tumors, or adenoid enlargement in the Ear, Nose, and Throat specialty. It is classified as FDA Class 2, requiring 510(k) premarket clearance to demonstrate substantial equivalence to an existing legally marketed device. The product code is EOB, regulated under 21 CFR 874.4760 in the Ear, Nose, Throat specialty. This device is eligible for third-party review. If the device is reusable, validated reprocessing instructions and reprocessing validation data must be included in the 510(k) submission.

View on FDA

510(k)s

162

FEI Numbers

132

Registration Numbers

132

Unique Applicants

Years Active

Basic Information

Product Code: EOB
Device Class: FDA class 2
Regulation Number: 874.4760
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 162 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261544	Hydro Irrigation System	Jun 17, 2026	Substantially Equivalent	Stryker Instruments
K254133	ENTity USB Videoscope System	May 14, 2026	Substantially Equivalent	Optim, LLC
K253184	Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)	Mar 25, 2026	Substantially Equivalent	Zhuhai Wesee Meditech Co., Ltd.
K252050	Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D	Mar 20, 2026	Substantially Equivalent	Olympus Medical Systems Corporation
K241731	Outlook Surgical Versa One System (8900139)	Aug 11, 2025	Substantially Equivalent	Resnent, LLC
K243639	Portare System (FA-001)	Jun 05, 2025	Substantially Equivalent	Grumpy Innovation, Inc.
K243380	VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)	Mar 03, 2025	Substantially Equivalent	Olympus Medical Systems Corporation
K234096	MonoStereo	Sep 19, 2024	Substantially Equivalent	Medicaltek Co., Ltd.
K232435	Rhinolaryngoscope system	Apr 26, 2024	Substantially Equivalent	Shenzhen HugeMed Medical Technical Development Co., Ltd.
K232015	ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0)	Aug 03, 2023	Substantially Equivalent	Atmos Medizintechnik GmbH & Co. KG
K222587	PatCom Distal Chip Endoscope	Jul 28, 2023	Substantially Equivalent	H&A Mui Enterprises, Inc.
K230536	Single-use Flexible Rhinolaryngoscope; Digital Video Monitor	Jun 14, 2023	Substantially Equivalent	Hunan Vathin Medical Instrument Co., Ltd.
K221660	RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP	Dec 28, 2022	Substantially Equivalent	Olympus Medical Systems Corp.
K221581	Single-Use Flexible Rhinolaryngoscope	Nov 18, 2022	Substantially Equivalent	Hunan Vathin Medical Instrument Co., Ltd.
K220465	PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10	Nov 16, 2022	Substantially Equivalent	Pentax of America, Inc.
K221638	Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3	Sep 19, 2022	Substantially Equivalent	Olympus Medical Systems Corp.
K214050	ENT Nasopharyngoscope and Accessories	Jul 01, 2022	Substantially Equivalent	Medimaging Integrated Solution, Inc (Miis)
K220004	Zsquare ENT-Flex Endoscope	Jun 14, 2022	Substantially Equivalent	Zsquare, Ltd.
K202727	Peregrine Endoscopy System	Jul 23, 2021	Substantially Equivalent	3nt Medical , Ltd.
K200609	ENTity WiFi Video Nasopharyngoscope System	Jan 13, 2021	Substantially Equivalent	Optim, LLC
K200740	HD Video Rhino Laryngoscope	Aug 11, 2020	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K192305	Colibri Endoscopy System	Feb 27, 2020	Substantially Equivalent	3nt Medical , Ltd.
K192090	CMOS Video Rhino-Laryngoscope SSU	Jan 27, 2020	Substantially Equivalent	Karl Storz SE & CO. KG
K191102	Precision S 4K Sinuscope	Sep 06, 2019	Substantially Equivalent	Stryker
K183416	Rhino-Laryngo Videoscope Olympus ENF-VT3	Sep 06, 2019	Substantially Equivalent	Olympus Medical Systems Corp.
K190972	Ambu aScope 4 RhinoLaryngo Intervention	Jul 12, 2019	Substantially Equivalent	Ambu A/S
K183691	PENTAX Medical ENT Video Imaging System	Jun 12, 2019	Substantially Equivalent	Pentax of America, Inc.
K191080	Ambu aScope 4 RhinoLaryngo Slim	May 22, 2019	Substantially Equivalent	Ambu A/S
K182186	CMOS Video-Rhino-Laryngoscope System	Mar 22, 2019	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K182102	RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4	Feb 06, 2019	Substantially Equivalent	Olympus Medical Systems Corp.
K182846	PENTAX Medical EPK-3000 Video Imaging System	Jan 09, 2019	Substantially Equivalent	Pentax of America, Inc.
K181286	Ambu aScope RLS Slim	Nov 30, 2018	Substantially Equivalent	Ambu A/S
K181240	Rhino-Laryngo Fiberscope Olympus ENF-GP2	Oct 04, 2018	Substantially Equivalent	Olympus Medical Systems Corp.
K171011	PENTAX Medical VIVIDEO ENT Videoscope Solution	Jul 18, 2018	Substantially Equivalent	Pentax Medical
K173855	Sharpsite AC Rigid Endsocope	Apr 20, 2018	Substantially Equivalent	Medtronic Xomed, Inc.
K172156	PENTAX Medical EPK-3000 Video Imaging System	Apr 05, 2018	Substantially Equivalent	Pentax Medical
K171402	KARL STORZ Slim Nasopharyngolaryngoscope	Feb 02, 2018	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K170453	Medrobotics Flex Robotic System	Oct 19, 2017	Substantially Equivalent	Medrobotics Corporation
K161298	ShenDa Sinuscope	Aug 25, 2017	Substantially Equivalent	Shenyang Shenda Endoscope Co., Ltd.
K170285	AED Sinuscope	Aug 01, 2017	Substantially Equivalent	National Advanced Endoscopy Devices, Inc.
K162151	PENTAX Medical ENT Video Imaging System	Apr 20, 2017	Substantially Equivalent	Pentax of America, Inc.
K162410	TIPCAM 1S 3D System	Mar 02, 2017	Substantially Equivalent	Karl Storz Endoscopy America, Inc.
K162916	3NT endoscopy system	Feb 24, 2017	Substantially Equivalent	3nt Medical , Ltd.
K153701	ULYSS Multi View Sinuscope	Sep 09, 2016	Substantially Equivalent	Sopro-Comeg GmbH
K153009	ULTRA Telescopes	Apr 05, 2016	Substantially Equivalent	Olympus Winter & Ibe GmbH
K152531	InstaClear Lens Cleaner	Jan 15, 2016	Substantially Equivalent	Gyrus Acmi, Inc.
K150776	Medrobotics Flex System	Jul 17, 2015	Substantially Equivalent	Medrobotics Corporation
K143673	CMOS Video Nasopharyngoscope System	Mar 04, 2015	Substantially Equivalent	Schoelly Fiberoptic GmbH
K142249	SCHOELLY SINUSCOPE	Jan 27, 2015	Substantially Equivalent	Schoelly Fiberoptic GmbH
K131323	ECLERIS SINUSCOPE	Jun 09, 2014	Substantially Equivalent	Ecleris USA
K132433	ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE	Apr 24, 2014	Substantially Equivalent	Acclarent, Inc.
K132009	CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM	Apr 09, 2014	Substantially Equivalent	Schoelly Fiberoptic GmbH
K103467	CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM	Jun 28, 2012	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K110097	ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE	May 27, 2011	Substantially Equivalent	Acclarent, Inc.
K102733	VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR	May 18, 2011	Substantially Equivalent	Vision-Sciences, Inc.
K102366	FINESS ENDOSCOPE	Feb 15, 2011	Substantially Equivalent	Entellus Medical, Inc.
K100577	ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE	Jan 06, 2011	Substantially Equivalent	Acclarent, Inc.
K100125	VISION SCIENCES FLEXIBLE ENT SCOPE	Feb 25, 2010	Substantially Equivalent	Vision-Sciences, Inc.
K083553	NASO-LARYNGO-PHARYNGOSCOPE	Jan 16, 2009	Substantially Equivalent	Schoelly Imaging, Inc.
K080740	CLEARVIEW ENDOSCOPE COVER	Dec 31, 2008	Substantially Equivalent	Invotec International, Inc.
K082667	VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)	Oct 30, 2008	Substantially Equivalent	Visionsense, Ltd.
K082569	ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE	Sep 18, 2008	Substantially Equivalent	Entellus Medical, Inc.
K080622	ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105	Apr 02, 2008	Substantially Equivalent	Optim, Inc.
K072387	KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES	Sep 13, 2007	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K072073	VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR	Aug 29, 2007	Substantially Equivalent	Vision-Sciences, Inc.
K070580	NASOPHARYNGOSCOPE, BRONCHOSCOPE	Jun 13, 2007	Substantially Equivalent	Xion GmbH
K070752	KSEA MINIATURE ENDOSCOPE, MODEL 11565	May 01, 2007	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K063078	MICROENDOSCOPE	Oct 24, 2006	Substantially Equivalent	Acclarent, Inc.
K061663	ENDOMEDICAL TECHNOLOGIES QUIK-COVER FLEXIBLE ENDOSCOPE BARRIER SHEATH FOR OTOLARYNGOSCOPES AND BRONCHOSCOPES	Sep 06, 2006	Substantially Equivalent	Rtc Inc.-Memcath Technologies, LLC
K052452	VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT	Sep 21, 2005	Substantially Equivalent	Olympus Medical Systems Corporation
K050972	VISION-SCIENCES ENT-3000 SCOPE	Apr 29, 2005	Substantially Equivalent	Vision-Sciences, Inc.
K040984	VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE	Apr 27, 2004	Substantially Equivalent	Vision-Sciences, Inc.
K032822	ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0	Jan 08, 2004	Substantially Equivalent	Asap Endoscopic Products GmbH
K030857	MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES	Oct 16, 2003	Substantially Equivalent	Mahe Intl., Inc.
K031648	VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V	Jul 24, 2003	Substantially Equivalent	Olympus Optical Co., Ltd.
K031790	SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING	Jul 02, 2003	Substantially Equivalent	Vision-Sciences, Inc.
K030572	HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE	Apr 01, 2003	Substantially Equivalent	Henke Sass Wolf of America, Inc.
K023004	LFRE INDIRECT LARYNGOSCOPE	Jan 28, 2003	Substantially Equivalent	Astralite Corp.
K024095	MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM	Jan 09, 2003	Substantially Equivalent	Vision-Sciences, Inc.
K012543	VISION SCIENCES ENDOSHEATH SYSTEM	Jul 15, 2002	Substantially Equivalent	Vision-Sciences, Inc.
K021073	VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V	May 01, 2002	Substantially Equivalent	Olympus America, Inc.
K020599	MTP CLEARVISION DISPOSABLE TUBING SET	Mar 13, 2002	Substantially Equivalent	Mtp Medical Technical Promotion GmbH
K013838	KSEA CLEARVISION LENS IRRIGATION SYSTEM	Jan 16, 2002	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K013591	XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT	Dec 26, 2001	Substantially Equivalent	Olympus Optical Co., Ltd.
K011869	XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT	Jul 25, 2001	Substantially Equivalent	The Olympus Optical Co.
K003830	ENT ENDOSCOPES	Apr 09, 2001	Substantially Equivalent	Global Endoscopy, Inc.
K002214	SINUSCOPE AND BACCESSORIES	Nov 21, 2000	Substantially Equivalent	Pollux Endoscopy, Inc.
K002700	KSEA UNIMAT 12	Oct 18, 2000	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K992526	FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE	Sep 24, 1999	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K991560	NASO-LARYNGO-PHARYNGOSCOPE	Jul 13, 1999	Substantially Equivalent	Fiber Imaging Technologies, Inc.
K990354	ENDOSHEATH	Mar 31, 1999	Substantially Equivalent	Vision-Sciences, Inc.
K990213	HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET	Feb 02, 1999	Substantially Equivalent	Gyrus Ent LLC
K984369	DCI ENDOSCOPE	Jan 29, 1999	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K983123	POC ENT ENDOSCOPE - SINUSCOPE	Sep 25, 1998	Substantially Equivalent	Precision Optics Corp.
K982594	ENDO-SCRUB/ENDO-SCRUB 2	Aug 27, 1998	Substantially Equivalent	Xomed, Inc.
K981751	SINUSCOPE AND ACCESSORIES	Aug 13, 1998	Substantially Equivalent	Henke Sass Wolf of America, Inc.
K981458	KSEA RHINO-LARYNGO-BRONCHO-FIBERSCOPE,PEDIATRIC BRONCHO-FIBERSCOPE, AND BRONCHO-FIBERSCOPE,11001RK, 11002BC & 110	May 20, 1998	Substantially Equivalent	Karl Storz Endoscopy
K972450	FLEXTIP GRASPER	Nov 21, 1997	Substantially Equivalent	Endius, Inc.
K971375	GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE	Oct 31, 1997	Substantially Equivalent	Wilson Greatbatch Technologies, Inc.
K972855	KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES	Sep 08, 1997	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K971995	MEDIVISION SINOSCOPE	Jun 26, 1997	Substantially Equivalent	Medivision Scope Service Center, Inc.
K965233	SHARPSITE AC	Apr 04, 1997	Substantially Equivalent	Xomed, Inc.
K970247	SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE	Mar 21, 1997	Substantially Equivalent	Smith & Nephew, Inc.
K962116	GALILEO ENDOSCOPES	Nov 27, 1996	Substantially Equivalent	Galileo Electro-Optics Corp.
K963757	IRRIGATION/SUCTION HANDLE AND SHEATH	Nov 26, 1996	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K963426	KARL STORZ CONTACT MICRO-LARYNGOSCOPES	Nov 07, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K962255	CLARUS MURPHYPEN ENDOSCOPE(2127-XXX)	Sep 11, 1996	Substantially Equivalent	Clarus Medical Systems, Inc.
K962898	KSEA UNIMAT PLUS	Aug 27, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K962396	KSEA BIPOLAR GOAGULATING FORCEPS	Aug 27, 1996	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K950809	VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES	Aug 05, 1996	Substantially Equivalent	Vision-Sciences, Inc.
K961591	DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE	Jul 02, 1996	Substantially Equivalent	Vision-Sciences, Inc.
K960876	FIVE STAR BRONCHOSCOPE	May 08, 1996	Substantially Equivalent	Five Star Medical, Inc.
K955560	TREBAY SCOPE IRRIGATED CLEARING SLEEVE	Dec 22, 1995	Substantially Equivalent	Trebay Medical Corp.
K942265	FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH	Dec 22, 1995	Substantially Equivalent	Vision-Sciences, Inc.
K953771	OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS	Nov 22, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K954348	GLANZ CARCINOMA GAUGE, KSEA	Nov 15, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K954336	ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)	Nov 13, 1995	Substantially Equivalent	Aust & Taylor Medical Corp.
K953888	TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L 14CM, AUTOCLAVABLE	Oct 07, 1995	Substantially Equivalent	Vista Medical Technologies, Inc.
K940317	SINUSCOPE	May 24, 1995	Substantially Equivalent	Stephen Chakoff, Inc.
K951249	CITATION SINUSCOPE	Apr 10, 1995	Substantially Equivalent	Citation Medical Corp.
K951196	FNL-10P, FIBER NASOPARHYNGOSCOPE	Apr 07, 1995	Substantially Equivalent	Pentax Precision Instrument Corp.
K951201	KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE	Apr 06, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K940028	ENDOSCOPE SHEATH	Mar 24, 1995	Substantially Equivalent	Xomed-Treace, Inc.
K945081	TRANSTYMPANIC ENDOSCOPE	Mar 06, 1995	Substantially Equivalent	Endooptiks, Inc.
K950603	KARL STORZ VISCOUS FLUID INJECTION SET	Feb 27, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K950334	KARL STORZ TELE-SCRUB	Feb 27, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K950338	KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS	Feb 24, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K944861	KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE	Feb 21, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K946011	ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM	Feb 17, 1995	Substantially Equivalent	Argus Medical Co., Inc.
K946148	KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES	Feb 09, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K944671	VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})	Feb 07, 1995	Substantially Equivalent	Jedmed Instrument Co.
K944670	JARIT RECOMMENDED SINUS INSTRUMENTS	Feb 02, 1995	Substantially Equivalent	J. Jamner Surgical Instruments, Inc.
K944656	OPTUS SINUSCOPES AND ACCESSORIES	Jan 26, 1995	Substantially Equivalent	Optus, Inc.
K945788	KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES	Jan 25, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K945381	NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES	Jan 18, 1995	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K944072	OLYMPUS NASAL AND SINUS ENDOSCOPES	Jan 11, 1995	Substantially Equivalent	Olympus America, Inc.
K944797	KARL STORZ INSULATED CANNULAE, SUCTION TUBES	Nov 22, 1994	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K944298	KARL STORZ INSULATED SCISSORS	Nov 22, 1994	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K944186	SINUSCOPE	Nov 07, 1994	Substantially Equivalent	Stryker Endoscopy
K944296	KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR	Oct 14, 1994	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K943665	NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS	Oct 11, 1994	Substantially Equivalent	Olympus America, Inc.
K943816	TROCARS,CANNULAE, SHEATHS	Aug 24, 1994	Substantially Equivalent	Karl Storz Endoskop GmbH
K943074	FORCEPS, PUNCHES, SCISSORS	Aug 02, 1994	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K933672	XOMED-TREACE SCOPESHEATH	Jul 18, 1994	Substantially Equivalent	Xomed-Treace, Inc.
K941565	JARIT RECOMMENDED SINUS INSTRUMENTS	May 16, 1994	Substantially Equivalent	J. Jamner Surgical Instruments, Inc.
K936257	ULTRATHIN FLEXIBLE ENDOSCOPE TAS-211/2.3	Mar 24, 1994	Substantially Equivalent	Mitsubishi Cable America, Inc.
K934422	NASOPHARYNGOSCOPE	Jan 27, 1994	Substantially Equivalent	Marks & Murase
K933105	XOMED-TREACE RIGID ROD LENS ENDOSCOPE	Jan 05, 1994	Substantially Equivalent	Xomed-Treace, Inc.
K933247	PROTECTIVE SHEATH FOR FLEXIBLE NASOPHARY/LARYGNOS	Nov 22, 1993	Substantially Equivalent	Vision-Sciences, Inc.
K932988	ACCESSORIES FOR ENDOSCOPES FOR SINUS SURGERY	Jul 26, 1993	Substantially Equivalent	Smith & Nephew Richards, Inc.
K930931	NASAL/PARANASAL ENDOSCOPE	May 17, 1993	Substantially Equivalent	Storz Instrument Co.
K925421	ENDOSHEATH	Jan 15, 1993	Substantially Equivalent	Vision-Sciences, Inc.
K921244	DISPOSABLE PROTECTIVE SHEATH	Oct 06, 1992	Substantially Equivalent	Vision-Sciences, Inc.
K920439	OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE	Sep 04, 1992	Substantially Equivalent	Omega Universal Technologies, Ltd.
K921707	PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2	Jul 01, 1992	Substantially Equivalent	Pentax Precision Instrument Corp.
K902683	SCOPESCRUBBER(TM)	Oct 31, 1990	Substantially Equivalent	Healthtek Microsurgical, Inc.
K900176	ENT-2 FLEXIBLE NASOPHARYGNO-LARYNGOSCOPES	Apr 10, 1990	Substantially Equivalent	Machida, Inc.
K896297	FLEXIBLE NASOPHARYNGOSCOPE	Jan 26, 1990	Substantially Equivalent	Jedmed Instrument Co.
K895245	FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE	Nov 17, 1989	Substantially Equivalent	Optimed Technologies, Inc.
K882744	EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM	Aug 10, 1988	Substantially Equivalent	Effner, Inc.
K874215	ENDOSCOPES FOR SINUS SURGERY	Jan 04, 1988	Substantially Equivalent	Richards Medical Co., Inc.
K864821	AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2	Feb 10, 1987	Substantially Equivalent	Reichert-Jung, Inc.

FEI Numbers

This FDA classification entry is associated with 132 FEI numbers. Click on an entry to view related FDA registrations.

1000022662: 1 registration

1000080301: 1 registration

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