Product Code: GAD
FDA class 1
21 CFR 878.4800
Retractor
General, Plastic Surgery
The Retractor (product code GAD) is a surgical instrument used to hold back tissue, organs, or wound edges to maintain clear visualization and access to the operative field during general and plastic surgery procedures. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket notification requirement. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
510(k)s
100
FEI Numbers
658
Registration Numbers
658
Unique Applicants
70
Years Active
40
Basic Information
- Product Code
- GAD
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 100 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K152538 | JRP Wound Spreader | Apr 13, 2016 | Substantially Equivalent | J.R. PARKER, LLC |
| K151104 | OTELO LL | Jan 06, 2016 | Substantially Equivalent | SPINEART |
| K132645 | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES | Oct 04, 2013 | Substantially Equivalent | MEDTRONIC, INC. |
| K071775 | DASH | Aug 07, 2007 | Substantially Equivalent | EZSURGICAL |
| K050256 | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | Apr 26, 2005 | Substantially Equivalent | APPLE MEDICAL CORP. |
| K043602 | QUADRANT RETRACTOR SYSTEM | Feb 23, 2005 | Substantially Equivalent | MEDTRONIC SOFAMOR DANEK |
| K001339 | MRI FASTSYSTEM RETRACTOR SYSTEM | May 17, 2000 | Substantially Equivalent | OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. |
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | Aug 18, 1998 | Substantially Equivalent | CLARUS MEDICAL SYSTEMS, INC. |
| K963006 | SCION SAPHENOUS VEIN HARVESTING SYSTEM | Sep 20, 1996 | Substantially Equivalent | SCION INTERNATIONAL, INC. |
| K943875 | VILLALTA RETRACTOR | Nov 09, 1994 | Substantially Equivalent | HCT, INC. |
| K942002 | RETRACTOR | May 17, 1994 | Substantially Equivalent | AUTOMATED MEDICAL PRODUCTS CORP. |
| K941448 | RETRACTOR | Apr 15, 1994 | Substantially Equivalent | TECHNOVATIONS |
| K930316 | LUNG RETRACTORS: DAVIDSON, SEMB | Feb 10, 1994 | Substantially Equivalent | THOMASVILLE MEDICAL ASSOC. |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | Aug 06, 1993 | Substantially Equivalent | T. KOROS SURGICAL INSTRUMENTS CORP. |
| K921020 | HARGIS SELF RETRACTION SYSTEM | Jul 02, 1993 | Substantially Equivalent | MEDIN CORP. |
| K921019 | HARGIS RECTAL SELF RETRATION SYSTEM | Jul 02, 1993 | Substantially Equivalent | MEDIN CORP. |
| K921017 | HARGIS SR2 SELF-RETRACTION SYSTEM | Jul 02, 1993 | Substantially Equivalent | MEDIN CORP. |
| K922626 | ADEPT INSTRUMENT POSITIONING ACCESSORY | Oct 19, 1992 | Substantially Equivalent | ANDRONIC DEVICES, LTD. |
| K922625 | ADEPT ENDOSCOPIC POSITIONER | Oct 19, 1992 | Substantially Equivalent | ANDRONIC DEVICES, LTD. |
| K920471 | LEVY ARTICULATING RETRACTOR | Jun 23, 1992 | Substantially Equivalent | LIFEGUARD MEDICAL PRODUCTS, INC. |
| K914190 | AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR | May 06, 1992 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K915175 | REDDICK RETRACTOR | Apr 29, 1992 | Substantially Equivalent | IDEAL MEDICAL, INC. |
| K915158 | SUREBREATH DOME, E-Z BREATHER | Feb 12, 1992 | Substantially Equivalent | IPAX, INC. |
| K910975 | TEKDYNE MICRO RETRACTOR | Apr 01, 1991 | Substantially Equivalent | TEKDYNE |
| K903969 | SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET | Sep 05, 1990 | Substantially Equivalent | KARLIN TECHNOLOGY, INC. |
| K893871 | GOOTT BALFOUR BLADE | Aug 03, 1989 | Substantially Equivalent | ADEPT-MED INTL., INC. |
| K893869 | GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) | Aug 03, 1989 | Substantially Equivalent | ADEPT-MED INTL., INC. |
| K893121 | ROBOTRAC (TM) RETRACTOR ARM | Jun 01, 1989 | Substantially Equivalent | AESCULAP INSTRUMENTS CORP. |
| K891892 | ROLLET RETRACTOR | Apr 12, 1989 | Substantially Equivalent | ZINNANTI SURGICAL INSTRUMENTS, INC. |
| K891031 | KIRSCHNER RETRACTOR | Apr 06, 1989 | Substantially Equivalent | ZINNANTI SURGICAL INSTRUMENTS, INC. |
| K890820 | LOCKING WIRE GUIDE STYLET | Mar 22, 1989 | Substantially Equivalent | MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE |
| K890250 | SURGICAL WIRE CUTTERS | Jan 27, 1989 | Substantially Equivalent | KINETIC MEDICAL PRODUCTS |
| K890248 | SURGICAL RETRACTORS | Jan 27, 1989 | Substantially Equivalent | KINETIC MEDICAL PRODUCTS |
| K890247 | SURGICAL RETRACTORS | Jan 27, 1989 | Substantially Equivalent | KINETIC MEDICAL PRODUCTS |
| K884076 | SUREBREATH DOME | Oct 07, 1988 | Substantially Equivalent | IPAX, INC. |
| K882075 | SELF-RETAINING SOFT TISSUE RETRACTOR | Jun 16, 1988 | Substantially Equivalent | KARLIN TECHNOLOGY, INC. |
| K882074 | SUCTION RETRACTORS | Jun 16, 1988 | Substantially Equivalent | KARLIN TECHNOLOGY, INC. |
| K882112 | MURSE RETRACTOR | Jun 15, 1988 | Substantially Equivalent | EURO-AMERICAN MARKETING GROUP, INC. |
| K881157 | STERNUM SPREADER AND MITRAL VALVE RETRACTOR | Apr 06, 1988 | Substantially Equivalent | T. KOROS SURGICAL INSTRUMENTS CORP. |
| K881159 | I.M.A. RETRACTOR | Apr 05, 1988 | Substantially Equivalent | T. KOROS SURGICAL INSTRUMENTS CORP. |
| K881156 | UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR | Apr 05, 1988 | Substantially Equivalent | T. KOROS SURGICAL INSTRUMENTS CORP. |
| K880998 | STERNUM SPREADER, PEDIATRIC | Mar 21, 1988 | Substantially Equivalent | T. KOROS SURGICAL INSTRUMENTS CORP. |
| K880997 | SPRING RETRACTOR | Mar 21, 1988 | Substantially Equivalent | T. KOROS SURGICAL INSTRUMENTS CORP. |
| K880813 | SELF-RETAINING SOFT TISSUE RETRACTOR | Mar 11, 1988 | Substantially Equivalent | T. KOROS SURGICAL INSTRUMENTS CORP. |
| K880151 | HIP, FEMUR AND HUMERUS RETRACTOR | Feb 18, 1988 | Substantially Equivalent | TWENTY-FIRST CENTURY ORTHOPEDICS, INC. |
| K875289 | SUCTION RETRACTOR | Jan 22, 1988 | Substantially Equivalent | T. KOROS SURGICAL INSTRUMENTS CORP. |
| K874243 | ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000 | Nov 13, 1987 | Substantially Equivalent | PILLING CO. |
| K872919 | OMNI-TRACT CORRAL RETRACTOR | Aug 11, 1987 | Substantially Equivalent | MINNESOTA SCIENTIFIC, INC. |
| K870543 | STERI-TRACTOR WOUND RETRACTOR | Feb 24, 1987 | Substantially Equivalent | 3M COMPANY |
| K864424 | RAYLOR(TM) PROTECTIVE RETRACTOR | Nov 26, 1986 | Substantially Equivalent | CEDAR SURGICAL, INC. |
| K864384 | LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS | Nov 19, 1986 | Substantially Equivalent | LUXTEC CORP. |
| K862597 | VARIOUS SURGICAL INSTRUMENTS | Jul 23, 1986 | Substantially Equivalent | KONIG W.G., LTD. |
| K853947 | OMNI-TRACT CHEST WALL & LUNA RETRACTOR | Oct 16, 1985 | Substantially Equivalent | MINNESOTA SCIENTIFIC, INC. |
| K853796 | RAYLOR RETRACTORS | Oct 07, 1985 | Substantially Equivalent | CEDAR SURGICAL, INC. |
| K853114 | ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR | Aug 06, 1985 | Substantially Equivalent | AUSTRALIAN BIOMEDICAL CORPORATION LTD. |
| K852415 | TITANIUM PROBES | Aug 02, 1985 | Substantially Equivalent | LASER, INC. |
| K852567 | 3M FUKUDA TYPE RING RETRACTOR | Jul 09, 1985 | Substantially Equivalent | 3M COMPANY |
| K852530 | WEITIANER MASTOID 3 VS 4 BLUNT & SHARP PRONGS | Jun 28, 1985 | Substantially Equivalent | THE HUXLEY INSTRUMENT CORP. |
| K852330 | RETRACTOR, SURGICAL | Jun 27, 1985 | Substantially Equivalent | SCHOLTEN SURGICAL INSTRUMENTS, INC. |
| K851776 | 21-450 GELPI RETRACTOR | Jun 20, 1985 | Substantially Equivalent | ARTIBERIA |
| K851115 | FINOCCHIETO RIB RETRACTOR 1711-72 PCS. SS 303, 420 | Apr 25, 1985 | Substantially Equivalent | THE HUXLEY INSTRUMENT CORP. |
| K851108 | VOLKMAN RETRACTOR 699-576 PCS. SHARP-4 PRONGS SS42 | Apr 25, 1985 | Substantially Equivalent | THE HUXLEY INSTRUMENT CORP. |
| K844177 | COSGROVE MITRAL VALVE RETRACTOR | Nov 08, 1984 | Substantially Equivalent | KAPP SURGICAL INSTRUMENT, INC. |
| K843100 | INSTRUMENTS FOR MICRO ANASTOMOSIS | Sep 27, 1984 | Substantially Equivalent | DOWNS SURGICAL LTD. |
| K843216 | ECLIPSE HEART SUPPORT FOR CORONARY ARTER | Sep 20, 1984 | Substantially Equivalent | BIOTRAC LABORATORIES |
| K841625 | HOOK | Aug 27, 1984 | Substantially Equivalent | PLASTAFIL, INC. |
| K842992 | GRASSHOPPER - RETRACTOR | Aug 17, 1984 | Substantially Equivalent | NORTON TEXAS MEDICAL PRODUCTS |
| K842762 | OMNI-TRACT SURGICAL RETRACTOR SYS | Aug 17, 1984 | Substantially Equivalent | MINNESOTA SCIENTIFIC, INC. |
| K841009 | SURGICAL RETRACTORS-VARIOUS | May 01, 1984 | Substantially Equivalent | PREMIER DENTAL PRODUCTS CO. |
| K834142 | ADHESIVE TRACTION TAPE | Apr 23, 1984 | Substantially Equivalent | DEVON INDUSTRIES, INC. |
| K834196 | JAKOBI SURG. INSTRUMENTS #11 20/25/27/37 | Jan 27, 1984 | Substantially Equivalent | IMM ENTERPRISES LTD. |
| K834181 | H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 | Jan 27, 1984 | Substantially Equivalent | IMM ENTERPRISES LTD. |
| K832765 | FLEXI-TY | Jan 27, 1984 | Substantially Equivalent | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC |
| K833541 | SURGICAL INSTRUMENT | Nov 28, 1983 | Substantially Equivalent | HIRATA SANGYO CO. USA, INC. |
| K830585 | ANVIL RETRACTOR | May 27, 1983 | Substantially Equivalent | TWIN CITY SURGICAL, INC. |
| K830287 | ZIMMER SKIN PROTECTOR | Mar 09, 1983 | Substantially Equivalent | ZIMMER, INC. |
| K820377 | PILLING IDENTI-LOOPS | Mar 10, 1982 | Substantially Equivalent | NARCO SCIENTIFIC |
| K820290 | SELF RETAINING RETRACTOR FOR HAND SURG | Mar 05, 1982 | Substantially Equivalent | THE ANSPACH EFFORT, INC. |
| K812875 | SURGICAL LOOPS | Nov 20, 1981 | Substantially Equivalent | M-W LABORATORIES, INC. |
| K812389 | SURGICAL LOOPS | Nov 16, 1981 | Substantially Equivalent | BERKELEY MEDEVICES |
| K811759 | RETRACTING PROBES | Jul 20, 1981 | Substantially Equivalent | AMERICAN V. MUELLER |
| K802599 | ARTHROSCOPIC FAT PAD RETRACTOR | Oct 31, 1980 | Substantially Equivalent | THE ANSPACH EFFORT, INC. |
| K801699 | ETHICON RETRACTION TAPE | Sep 26, 1980 | Substantially Equivalent | ETHICON, INC. |
| K801759 | EFFRON PAROTID RETRACTOR | Aug 20, 1980 | Substantially Equivalent | AMERICAN V. MUELLER |
| K801611 | DEEP BALFOUR BLADE FOR WILKINSON RETRACT | Aug 04, 1980 | Substantially Equivalent | EDWARD WECK, INC. |
| K792145 | AUTOMATIC RETRACTOR HOLDERS | Dec 05, 1979 | Substantially Equivalent | AUTOMATED MEDICAL PRODUCTS, INC. |
| K781445 | SPREADER | Sep 27, 1979 | Substantially Equivalent | ORTHOPEDIC EQUIPMENT CO., INC. |
| K791665 | SCOTTS SURGICAL RETRACTOR AND ELASTIC | Sep 19, 1979 | Substantially Equivalent | LONE STAR MEDICAL PRODUCTS, INC. |
| K791122 | TISSURE RETRACTORS | Jul 10, 1979 | Substantially Equivalent | XOMED, INC. |
| K790952 | CLAMP COVERS | Jun 05, 1979 | Substantially Equivalent | MEDI-SPEC |
| K780720 | IDENTI-LOOPS | Oct 17, 1978 | Substantially Equivalent | BERKELEY BIO-MEDICAL, INC. |
| K780993 | ULTRASOUND IMAGING SYSTEM | Aug 10, 1978 | Substantially Equivalent | BOEHRINGER MANNHEIM CORP. |
| K780708 | AUTOMATIC RETRACTOR HOLDER | Jul 17, 1978 | Substantially Equivalent | GREAT EASTERN LUMBER CO., INC. |
| K772378 | NEIVS TRACHEOTOMY RETRACTOR | Mar 09, 1978 | Substantially Equivalent | EDWARD WECK, INC. |
| K771191 | HEISS RETRACTOR | Jul 11, 1977 | Substantially Equivalent | EDWARD WECK, INC. |
| K770414 | PROBE RETRACTOR, PART #S-2L8-6 | Apr 15, 1977 | Substantially Equivalent | ACME UNITED CORP. |
| K770651 | RETRACTORS & HOOKS, ABRAMSON | Apr 14, 1977 | Substantially Equivalent | EDWARD WECK, INC. |
| K770418 | RETRACTOR, SKIN HOOK | Mar 23, 1977 | Substantially Equivalent | ACME UNITED CORP. |
| K761096 | VANDERBILT PITUITARY RETRACTOR | Nov 30, 1976 | Substantially Equivalent | Codman & Shurtleff, Inc. |
| K760422 | SURGICAL RETRACTOR | Aug 23, 1976 | Substantially Equivalent | CUTTER LABORATORIES, INC. |
FEI Numbers
This FDA classification entry is associated with 658 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 658 registration numbers. Click on an entry to view related FDA registrations.