Clamp, Surgical, General & Plastic Surgery
FDA product code GDJ · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
32510(k) clearances
0PMA approvals
8recalls
Manufacturers
- Edward Weck, Inc. 5
- Med General 2
- Conphar, Inc. 2
- United States Surgical, A Division of Tyco Healthc 2
- The Huxley Instrument Corp. 1
- Standard Bariatrics 1
- Solos Endoscopy, Inc. 1
- Applied Medical Technologies 1
- Key Surgical, Inc. 1
- Henley Intl. 1
- Stuart-Lee, Inc. 1
- Med-Dex Intl. 1
- Dlp, Inc. 1
- Modern Medical Products 1
- Artiberia 1
- Talboy, Inc. 1
- Berkeley Medevices 1
- ETHICON, Inc. 1
- Cordis Corp. 1
- Berkeley Bio-Medical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153358 | Standard ClampGDJ · Traditional | Standard Bariatrics | 05/02/2016SE |
| K930315 | Thoracic Clamps: Sarot, Kantowitz and LawrenceGDJ · Traditional | Thomasville Medical Assoc. | 02/04/1994SE |
| K924223 | Mar-Med Liver StrapGDJ · Traditional | Mar-Med Co. | 03/18/1993SE |
| K922659 | General Surgery Clamp and Needle HolderGDJ · Traditional | Miltex Instrument Co. | 07/21/1992SE |
| K914913 | Grice Foot Pedal Control/Reddick Irri/Aspir SystGDJ · Traditional | Ideal Medical, Inc. | 12/31/1991SE |
| K900956 | GS-7100 Cholangiogram Clamp, 5MMGDJ · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K901107 | Modified Auto Suture Purstring Disp. AutomaticGDJ · Traditional | United States Surgical, A Division of Tyco Healthc | 04/09/1990SE |
| K895726 | Vessel OccluderGDJ · Traditional | Applied Medical Technologies | 10/24/1989SE |
| K895591 | Silicone Instrument ShodsGDJ · Traditional | Key Surgical, Inc. | 10/20/1989SE |
| K882169 | Surgical Duct Clamp (Vine)GDJ · Traditional | Henley Intl. | 06/17/1988SE |
| K881741 | Stuart Lee ClipGDJ · Traditional | Stuart-Lee, Inc. | 06/03/1988SE |
| K881084 | Utility ClampGDJ · Traditional | Med-Dex Intl. | 03/25/1988SE |
| K874428 | Auto Suture Purse String Applier*GDJ · Traditional | United States Surgical, A Division of Tyco Healthc | 12/02/1987SE |
| K855144 | Touriquet Kit with SnareGDJ · Traditional | Dlp, Inc. | 02/05/1986SE |
| K853583 | Modern Medical Products Towel ClampGDJ · Traditional | Modern Medical Products | 09/16/1985SE |
| K852724 | Backhaus Towel Clamp, 5-1/2 + SS 410 or 420GDJ · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K851774 | 17-900 to 17-980 Various Towel ClampsGDJ · Traditional | Artiberia | 06/20/1985SE |
| K843816 | Tal-ClipGDJ · Traditional | Talboy, Inc. | 10/31/1984SE |
| K812388 | Surgical PawsGDJ · Traditional | Berkeley Medevices | 11/16/1981SE |
| K801660 | Proximate * PSD Purse-String DeviceGDJ · Traditional | ETHICON, Inc. | 08/13/1980SE |
| K800074 | Vessel OccluderGDJ · Traditional | Cordis Corp. | 01/28/1980SE |
| K791802 | Conphar Tube ClampsGDJ · Traditional | Conphar, Inc. | 09/21/1979SE |
| K791800 | Conphar Umbilical Cord ClampGDJ · Traditional | Conphar, Inc. | 09/21/1979SE |
| K782006 | Medgeneral Single-Use BulldogGDJ · Traditional | Med General | 12/15/1978SE |
| K780721 | Identi-ClampsGDJ · Traditional | Berkeley Bio-Medical, Inc. | 10/17/1978SE |
| K780291 | Ulnar-Radial ApproximaterGDJ · Traditional | Edward Weck, Inc. | 02/28/1978SE |
| K780290 | Ulnar-Radial ClipGDJ · Traditional | Edward Weck, Inc. | 02/28/1978SE |
| K780288 | Bracheal-Large Vessel ClipGDJ · Traditional | Edward Weck, Inc. | 02/28/1978SE |
| K780286 | Brachial-Large Vessel ApproximatorGDJ · Traditional | Edward Weck, Inc. | 02/28/1978SE |
| K771701 | Vessel-CludeGDJ · Traditional | Med General | 12/13/1977SE |
| K771589 | Auto SutureGDJ · Traditional | U. S. Surgical Corp. | 12/13/1977SE |
| K760898 | Goldfarb Liver ClampGDJ · Traditional | Edward Weck, Inc. | 12/29/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0936-2025 Class II | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-2423-2024 Class II | TourniKwik Tourniquet Set (CFN 79012)Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set. | Medtronic Perfusion Systems | 05/16/2024Open, Classified |
| Z-1798-2024 Class II | Medtronic Tourniquet Sets: a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004…Potential for unsealed sterile packing. | Medtronic Perfusion Systems | 03/19/2024Open, Classified |
| Z-2595-2018 Class II | MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD Infinity XR2…There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Integra LifeSciences Corp. | 06/29/2018Terminated |
| Z-2594-2018 Class II | MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD Infinity…There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Integra LifeSciences Corp. | 06/29/2018Terminated |
| Z-2593-2018 Class II | MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD Infinity XR2…There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Integra LifeSciences Corp. | 06/29/2018Terminated |
| Z-2592-2018 Class II | MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD Infinity XR2 Base Unit…There is a potential for the knob assembly in the swivel adapter to fracture/break during use. | Integra LifeSciences Corp. | 06/29/2018Terminated |
| Z-2130-2013 Class II | Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM)…Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument. | Stryker Howmedica Osteonics Corp. | 07/02/2013Terminated |