Product code GAD
- Device name
- Retractor
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152538 | JRP Wound Spreader | J.R. Parker, LLC | 2016-04-13 |
| K151104 | OTELO LL | Spineart | 2016-01-06 |
| K132645 | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES | Medtronic, Inc. | 2013-10-04 |
| K071775 | DASH | Ezsurgical | 2007-08-07 |
| K050256 | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | Apple Medical Corp. | 2005-04-26 |
| K043602 | QUADRANT RETRACTOR SYSTEM | Medtronic Sofamor Danek | 2005-02-23 |
| K001339 | MRI FASTSYSTEM RETRACTOR SYSTEM | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 2000-05-17 |
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | Clarus Medical Systems, Inc. | 1998-08-18 |
| K963006 | SCION SAPHENOUS VEIN HARVESTING SYSTEM | Scion International, Inc. | 1996-09-20 |
| K943875 | VILLALTA RETRACTOR | Hct, Inc. | 1994-11-09 |
| K942002 | RETRACTOR | Automated Medical Products Corp. | 1994-05-17 |
| K941448 | RETRACTOR | Technovations | 1994-04-15 |
| K930316 | LUNG RETRACTORS: DAVIDSON, SEMB | Thomasville Medical Assoc. | 1994-02-10 |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | 1993-08-06 |
| K921017 | HARGIS SR2 SELF-RETRACTION SYSTEM | Medin Corp. | 1993-07-02 |
| K921019 | HARGIS RECTAL SELF RETRATION SYSTEM | Medin Corp. | 1993-07-02 |
| K921020 | HARGIS SELF RETRACTION SYSTEM | Medin Corp. | 1993-07-02 |
| K922625 | ADEPT ENDOSCOPIC POSITIONER | Andronic Devices, Ltd. | 1992-10-19 |
| K922626 | ADEPT INSTRUMENT POSITIONING ACCESSORY | Andronic Devices, Ltd. | 1992-10-19 |
| K920471 | LEVY ARTICULATING RETRACTOR | Lifeguard Medical Products, Inc. | 1992-06-23 |
| K914190 | AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR | United States Surgical, A Division of Tyco Healthc | 1992-05-06 |
| K915175 | REDDICK RETRACTOR | Ideal Medical, Inc. | 1992-04-29 |
| K915158 | SUREBREATH DOME, E-Z BREATHER | Ipax, Inc. | 1992-02-12 |
| K910975 | TEKDYNE MICRO RETRACTOR | Tekdyne | 1991-04-01 |
| K903969 | SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET | Karlin Technology, Inc. | 1990-09-05 |
| K893869 | GOOTT MULTIPURPOSE FLEXIBLE RETRACTOR (STERILE) | Adept-Med Intl., Inc. | 1989-08-03 |
| K893871 | GOOTT BALFOUR BLADE | Adept-Med Intl., Inc. | 1989-08-03 |
| K893121 | ROBOTRAC (TM) RETRACTOR ARM | Aesculap Instruments Corp. | 1989-06-01 |
| K891892 | ROLLET RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K891031 | KIRSCHNER RETRACTOR | Zinnanti Surgical Instruments, Inc. | 1989-04-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
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| 00810130207589 | MSI | Modern Surgical Instruments LLC | 2026-10-15 |
| 00810220800645 | Adler Instrument Company | Adler, Inc. | 2026-10-15 |
| 00810220800652 | Adler Instrument Company | Adler, Inc. | 2026-10-15 |
| 00810220800669 | Adler Instrument Company | Adler, Inc. | 2026-10-15 |
| 03661219013341 | LANDANGER | LANDANGER | 2026-10-15 |
| 10724995269316 | Snowden-Pencer | STERIS Deutschland GmbH | 2026-10-15 |
| 10724995269323 | Snowden-Pencer | STERIS Deutschland GmbH | 2026-10-15 |
| 00724995266936 | Snowden-Pencer | STERIS Deutschland GmbH | 2026-10-15 |
| 00842102116513 | DynaTrac Retractor Frames | FLEXBAR MACHINE CORPORATION | 2026-10-14 |
| 00192896123922 | Knurled Nut | SONTEC INSTRUMENTS, INC. | 2026-10-14 |
| 00190776434953 | Millennium | Avalign Technologies, Inc. | 2026-10-14 |
| G1415189430 | Carnegie Surgical LLC | Carnegie Surgical LLC | 2026-10-12 |
| 04058749044249 | NA | Fehling Instruments GmbH & Co. KG | 2026-10-12 |
| 00190776434700 | Millennium | Avalign Technologies, Inc. | 2026-10-12 |
| 00190776434663 | Millennium | Avalign Technologies, Inc. | 2026-10-12 |
| 00190776434632 | Millennium | Avalign Technologies, Inc. | 2026-10-12 |
| 00190776434144 | Millennium | Avalign Technologies, Inc. | 2026-10-09 |
| 00190776434205 | Millennium | Avalign Technologies, Inc. | 2026-10-09 |
| 00840217909815 | Ace Medical Company | EBNER MEDICAL, LLC | 2025-08-14 |
| 00840217909679 | Ace Medical Company | EBNER MEDICAL, LLC | 2025-06-02 |
| 00840217909440 | Ace Medical Company | EBNER MEDICAL, LLC | 2025-01-14 |
| 00840217909433 | Ace Medical Company | EBNER MEDICAL, LLC | 2025-01-08 |
| 00840217909426 | Ace Medical Company | EBNER MEDICAL, LLC | 2025-01-08 |
| 00840217907729 | Ebner | EBNER MEDICAL, LLC | 2023-06-07 |
| 00840217907712 | Ebner | EBNER MEDICAL, LLC | 2023-06-07 |
| 00840217907705 | Ebner | EBNER MEDICAL, LLC | 2023-06-07 |
| 00763000606183 | Medtronic Reusable Instruments | MEDTRONIC MINIMED, INC. | 2022-10-10 |
| 00840319711576 | Hayden Medical | Hayden Medical, Inc. | 2022-07-28 |
| 10885403105395 | V. Mueller | STERIS CORPORATION | 2018-09-10 |