FDA Product Code
FDA Product Code GAD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 100 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152538 | JRP Wound Spreader | J.R. Parker, LLC | 2016-04-13 | Traditional | PDF ↗ |
| K151104 | OTELO LL | Spineart | 2016-01-06 | Traditional | PDF ↗ |
| K132645 | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES | Medtronic, Inc. | 2013-10-04 | Traditional | PDF ↗ |
| K071775 | DASH | Ezsurgical | 2007-08-07 | Traditional | PDF ↗ |
| K050256 | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | Apple Medical Corp. | 2005-04-26 | Traditional | PDF ↗ |
| K043602 | QUADRANT RETRACTOR SYSTEM | Medtronic Sofamor Danek | 2005-02-23 | Traditional | PDF ↗ |
| K001339 | MRI FASTSYSTEM RETRACTOR SYSTEM | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 2000-05-17 | Special | PDF ↗ |
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | Clarus Medical Systems, Inc. | 1998-08-18 | Traditional | PDF ↗ |
| K963006 | SCION SAPHENOUS VEIN HARVESTING SYSTEM | Scion International, Inc. | 1996-09-20 | Traditional | PDF ↗ |
| K943875 | VILLALTA RETRACTOR | Hct, Inc. | 1994-11-09 | Traditional | PDF ↗ |
| K942002 | RETRACTOR | Automated Medical Products Corp. | 1994-05-17 | Traditional | PDF ↗ |
| K941448 | RETRACTOR | Technovations | 1994-04-15 | Traditional | PDF ↗ |
| K930316 | LUNG RETRACTORS: DAVIDSON, SEMB | Thomasville Medical Assoc. | 1994-02-10 | Traditional | PDF ↗ |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | 1993-08-06 | Traditional | PDF ↗ |
| K921020 | HARGIS SELF RETRACTION SYSTEM | Medin Corp. | 1993-07-02 | Traditional | PDF ↗ |
| K921019 | HARGIS RECTAL SELF RETRATION SYSTEM | Medin Corp. | 1993-07-02 | Traditional | PDF ↗ |
| K921017 | HARGIS SR2 SELF-RETRACTION SYSTEM | Medin Corp. | 1993-07-02 | Traditional | PDF ↗ |
| K922626 | ADEPT INSTRUMENT POSITIONING ACCESSORY | Andronic Devices, Ltd. | 1992-10-19 | Traditional | PDF ↗ |
| K922625 | ADEPT ENDOSCOPIC POSITIONER | Andronic Devices, Ltd. | 1992-10-19 | Traditional | PDF ↗ |
| K920471 | LEVY ARTICULATING RETRACTOR | Lifeguard Medical Products, Inc. | 1992-06-23 | Traditional | PDF ↗ |
| K914190 | AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR | United States Surgical, A Division of Tyco Healthc | 1992-05-06 | Traditional | PDF ↗ |
| K915175 | REDDICK RETRACTOR | Ideal Medical, Inc. | 1992-04-29 | Traditional | PDF ↗ |
| K915158 | SUREBREATH DOME, E-Z BREATHER | Ipax, Inc. | 1992-02-12 | Traditional | PDF ↗ |
| K910975 | TEKDYNE MICRO RETRACTOR | Tekdyne | 1991-04-01 | Traditional | PDF ↗ |
| K903969 | SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET | Karlin Technology, Inc. | 1990-09-05 | Traditional | PDF ↗ |
| K893871 | GOOTT BALFOUR BLADE | Adept-Med Intl., Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K893869 | GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) | Adept-Med Intl., Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K893121 | ROBOTRAC (TM) RETRACTOR ARM | Aesculap Instruments Corp. | 1989-06-01 | Traditional | PDF ↗ |
| K891892 | ROLLET RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-04-12 | Traditional | PDF ↗ |
| K891031 | KIRSCHNER RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-04-06 | Traditional | PDF ↗ |
| K890820 | LOCKING WIRE GUIDE STYLET | Medical Engineering and Development Institute | 1989-03-22 | Traditional | PDF ↗ |
| K890247 | SURGICAL RETRACTORS | Kinetic Medical Products | 1989-01-27 | Traditional | PDF ↗ |
| K890248 | SURGICAL RETRACTORS | Kinetic Medical Products | 1989-01-27 | Traditional | PDF ↗ |
| K890250 | SURGICAL WIRE CUTTERS | Kinetic Medical Products | 1989-01-27 | Traditional | PDF ↗ |
| K884076 | SUREBREATH DOME | Ipax, Inc. | 1988-10-07 | Traditional | PDF ↗ |
| K882075 | SELF-RETAINING SOFT TISSUE RETRACTOR | Karlin Technology, Inc. | 1988-06-16 | Traditional | PDF ↗ |
| K882074 | SUCTION RETRACTORS | Karlin Technology, Inc. | 1988-06-16 | Traditional | PDF ↗ |
| K882112 | MURSE RETRACTOR | Euro-American Marketing Group, Inc. | 1988-06-15 | Traditional | PDF ↗ |
| K881157 | STERNUM SPREADER AND MITRAL VALVE RETRACTOR | T. Korossurgical Instruments Corp. | 1988-04-06 | Traditional | PDF ↗ |
| K881159 | I.M.A. RETRACTOR | T. Korossurgical Instruments Corp. | 1988-04-05 | Traditional | PDF ↗ |
| K881156 | UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR | T. Korossurgical Instruments Corp. | 1988-04-05 | Traditional | PDF ↗ |
| K880998 | STERNUM SPREADER, PEDIATRIC | T. Korossurgical Instruments Corp. | 1988-03-21 | Traditional | PDF ↗ |
| K880997 | SPRING RETRACTOR | T. Korossurgical Instruments Corp. | 1988-03-21 | Traditional | PDF ↗ |
| K880813 | SELF-RETAINING SOFT TISSUE RETRACTOR | T. Korossurgical Instruments Corp. | 1988-03-11 | Traditional | PDF ↗ |
| K880151 | HIP, FEMUR AND HUMERUS RETRACTOR | Twenty-First Century Orthopedics, Inc. | 1988-02-18 | Traditional | PDF ↗ |
| K875289 | SUCTION RETRACTOR | T. Korossurgical Instruments Corp. | 1988-01-22 | Traditional | PDF ↗ |
| K874243 | ABDOMINAL/VASCULAR RETRACTOR-SPLIT WISHBONE 163000 | Pilling Co. | 1987-11-13 | Traditional | PDF ↗ |
| K872919 | OMNI-TRACT CORRAL RETRACTOR | Minnesota Scientific, Inc. | 1987-08-11 | Traditional | PDF ↗ |
| K870543 | STERI-TRACTOR WOUND RETRACTOR | 3M Company | 1987-02-24 | Traditional | PDF ↗ |
| K864424 | RAYLOR(TM) PROTECTIVE RETRACTOR | Cedar Surgical, Inc. | 1986-11-26 | Traditional | PDF ↗ |
| K864384 | LUXTEC RETRACTORS, LUXTEC SPECIALTY RETRACTORS | Luxtec Corp. | 1986-11-19 | Traditional | PDF ↗ |
| K862597 | VARIOUS SURGICAL INSTRUMENTS | Konig W.G., Ltd. | 1986-07-23 | Traditional | PDF ↗ |
| K853947 | OMNI-TRACT CHEST WALL & LUNA RETRACTOR | Minnesota Scientific, Inc. | 1985-10-16 | Traditional | PDF ↗ |
| K853796 | RAYLOR RETRACTORS | Cedar Surgical, Inc. | 1985-10-07 | Traditional | PDF ↗ |
| K853114 | ROTALOK WRIST STRAP, ROTALOK SKIN RETRACTOR | Australian Biomedical Corporation , Ltd. | 1985-08-06 | Traditional | PDF ↗ |
| K852415 | TITANIUM PROBES | L.A.S.E.R., Inc. | 1985-08-02 | Traditional | PDF ↗ |
| K852567 | 3M FUKUDA TYPE RING RETRACTOR | 3M Company | 1985-07-09 | Traditional | PDF ↗ |
| K852530 | WEITIANER MASTOID 3 VS 4 BLUNT & SHARP PRONGS | The Huxley Instrument Corp. | 1985-06-28 | Traditional | PDF ↗ |
| K852330 | RETRACTOR, SURGICAL | Scholten Surgical Instruments, Inc. | 1985-06-27 | Traditional | PDF ↗ |
| K851776 | 21-450 GELPI RETRACTOR | Artiberia | 1985-06-20 | Traditional | PDF ↗ |
| K851115 | FINOCCHIETO RIB RETRACTOR 1711-72 PCS. SS 303, 420 | The Huxley Instrument Corp. | 1985-04-25 | Traditional | PDF ↗ |
| K851108 | VOLKMAN RETRACTOR 699-576 PCS. SHARP-4 PRONGS SS42 | The Huxley Instrument Corp. | 1985-04-25 | Traditional | PDF ↗ |
| K844177 | COSGROVE MITRAL VALVE RETRACTOR | Kapp Surgical Instrument, Inc. | 1984-11-08 | Traditional | PDF ↗ |
| K843100 | INSTRUMENTS FOR MICRO ANASTOMOSIS | Downs Surgical , Ltd. | 1984-09-27 | Traditional | PDF ↗ |
| K843216 | ECLIPSE HEART SUPPORT FOR CORONARY ARTER | Biotrac Laboratories | 1984-09-20 | Traditional | PDF ↗ |
| K841625 | HOOK | Plastafil, Inc. | 1984-08-27 | Traditional | PDF ↗ |
| K842762 | OMNI-TRACT SURGICAL RETRACTOR SYS | Minnesota Scientific, Inc. | 1984-08-17 | Traditional | PDF ↗ |
| K842992 | GRASSHOPPER - RETRACTOR | Norton Texas Medical Products | 1984-08-17 | Traditional | PDF ↗ |
| K841009 | SURGICAL RETRACTORS-VARIOUS | Premier Dental Products Co. | 1984-05-01 | Traditional | PDF ↗ |
| K834142 | ADHESIVE TRACTION TAPE | Devon Industries, Inc. | 1984-04-23 | Traditional | PDF ↗ |
| K832765 | FLEXI-TY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-01-27 | Traditional | PDF ↗ |
| K834181 | H.R. JAKOBI SURG. INSTRUMENTS #11 16/46 | Imm Enterprises , Ltd. | 1984-01-27 | Traditional | PDF ↗ |
| K834196 | JAKOBI SURG. INSTRUMENTS #11 20/25/27/37 | Imm Enterprises , Ltd. | 1984-01-27 | Traditional | PDF ↗ |
| K833541 | SURGICAL INSTRUMENT | Hirata Sangyo Co. USA, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K830585 | ANVIL RETRACTOR | Twin City Surgical, Inc. | 1983-05-27 | Traditional | PDF ↗ |
| K830287 | ZIMMER SKIN PROTECTOR | Zimmer, Inc. | 1983-03-09 | Traditional | PDF ↗ |
| K820377 | PILLING IDENTI-LOOPS | Narco Scientific | 1982-03-10 | Traditional | PDF ↗ |
| K820290 | SELF RETAINING RETRACTOR FOR HAND SURG | The Anspach Effort, Inc. | 1982-03-05 | Traditional | PDF ↗ |
| K812875 | SURGICAL LOOPS | M-W Laboratories, Inc. | 1981-11-20 | Traditional | PDF ↗ |
| K812389 | SURGICAL LOOPS | Berkeley Medevices | 1981-11-16 | Traditional | PDF ↗ |
| K811759 | RETRACTING PROBES | American V. Mueller | 1981-07-20 | Traditional | PDF ↗ |
| K802599 | ARTHROSCOPIC FAT PAD RETRACTOR | The Anspach Effort, Inc. | 1980-10-31 | Traditional | PDF ↗ |
| K801699 | ETHICON RETRACTION TAPE | ETHICON, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K801759 | EFFRON PAROTID RETRACTOR | American V. Mueller | 1980-08-20 | Traditional | PDF ↗ |
| K801611 | DEEP BALFOUR BLADE FOR WILKINSON RETRACT | Edward Weck, Inc. | 1980-08-04 | Traditional | PDF ↗ |
| K792145 | AUTOMATIC RETRACTOR HOLDERS | Automated Medical Products, Inc. | 1979-12-05 | Traditional | PDF ↗ |
| K781445 | SPREADER | Orthopedic Equipment Co., Inc. | 1979-09-27 | Traditional | PDF ↗ |
| K791665 | SCOTTS SURGICAL RETRACTOR AND ELASTIC | Lone Star Medical Products, Inc. | 1979-09-19 | Traditional | PDF ↗ |
| K791122 | TISSURE RETRACTORS | Xomed, Inc. | 1979-07-10 | Traditional | PDF ↗ |
| K790952 | CLAMP COVERS | Medi-Spec | 1979-06-05 | Traditional | PDF ↗ |
| K780720 | IDENTI-LOOPS | Berkeley Bio-Medical, Inc. | 1978-10-17 | Traditional | PDF ↗ |
| K780993 | ULTRASOUND IMAGING SYSTEM | Boehringer Mannheim Corp. | 1978-08-10 | Traditional | PDF ↗ |
| K780708 | AUTOMATIC RETRACTOR HOLDER | Great Eastern Lumber Co., Inc. | 1978-07-17 | Traditional | PDF ↗ |
| K772378 | NEIVS TRACHEOTOMY RETRACTOR | Edward Weck, Inc. | 1978-03-09 | Traditional | PDF ↗ |
| K771191 | HEISS RETRACTOR | Edward Weck, Inc. | 1977-07-11 | Traditional | PDF ↗ |
| K770414 | PROBE RETRACTOR, PART #S-2L8-6 | Acme United Corp. | 1977-04-15 | Traditional | PDF ↗ |
| K770651 | RETRACTORS & HOOKS, ABRAMSON | Edward Weck, Inc. | 1977-04-14 | Traditional | PDF ↗ |
| K770418 | RETRACTOR, SKIN HOOK | Acme United Corp. | 1977-03-23 | Traditional | PDF ↗ |
| K761096 | VANDERBILT PITUITARY RETRACTOR | Codman & Shurtleff, Inc. | 1976-11-30 | Traditional | PDF ↗ |
| K760422 | SURGICAL RETRACTOR | Cutter Laboratories, Inc. | 1976-08-23 | Traditional | PDF ↗ |
Product code GAD · Class I · General, Plastic Surgery. Data: openFDA.