Cutter, Surgical
FDA product code FZT · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
52510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Conphar, Inc. 21
- Dentronix, Inc. 5
- Edward Weck, Inc. 5
- Sea-Pac Trading Corp. 4
- J. Sklar Mfg. Co., Inc. 2
- Laschal Instrument Corp. 2
- Nuscience Consulting and Management Group, LLC 1
- United States Surgical, A Division of Tyco Healthc 1
- Micrins Surgical, Inc. 1
- Paris Products, Inc. 1
- Surgical Products Corp. 1
- Fred Sammons, Inc. 1
- Medcare Products 1
- Devco Medical Industries, Inc. 1
- Macon & Co., Inc. 1
- Sara Dan, Inc. 1
- E.M. Adams 1
- Procter & Gamble Mfg. Co. 1
- Depuy, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112400 | SmartshearsFZT · Traditional | Nuscience Consulting and Management Group, LLC | 09/12/2011SE |
| K890818 | Auto Suture Disposable Surgical Trocar*FZT · Traditional | United States Surgical, A Division of Tyco Healthc | 05/04/1989SE |
| K872990 | Micrins Surgical ScissorFZT · Traditional | Micrins Surgical, Inc. | 08/17/1987SE |
| K841741 | Single Hair Transplant GraftFZT · Traditional | Paris Products, Inc. | 07/23/1984SE |
| K841247 | SPC Disposable CutterFZT · Traditional | Surgical Products Corp. | 05/02/1984SE |
| K822448 | Scissors, VariousFZT · Traditional | J. Sklar Mfg. Co., Inc. | 09/14/1982SE |
| K821632 | Surgical Scissors, Set of 3FZT · Traditional | Fred Sammons, Inc. | 06/24/1982SE |
| K821361 | Conphar Tonsil ScissorsFZT · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821355 | Conphar Littauer ScissorsFZT · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821352 | Conphar Iris ScissorsFZT · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821351 | Conphar Dissecting ScissorsFZT · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821350 | Conphar Wire Cutting ScissorsFZT · Traditional | Conphar, Inc. | 05/27/1982SE |
| K821126 | Lister Bandage Scissors 3 & 1/2FZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821125 | Operating Scissors 5 &1/2 Sharp Blunt&FZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821124 | Scissors 6 & 1/2 Sharp/BluntFZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821123 | Lister Bandage Scissors 7 & 1/2FZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821122 | Operating 5 & 1/2 Straigh Sharp/BluntFZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821121 | Scissors 5 & 1/2STRAIGHT Blunt/BluntFZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821120 | Operating Scissors Curved 4 & 1/2 BluntFZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821119 | Operating Scissors 4 & 1/2 Blunt/BluntFZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821118 | Bandage Scissors 4 & 1/2FZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821117 | Scissors Straight 5&1/2SHARPFZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821116 | Lister Bandage Scissors 5 & 1/2FZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821115 | Scissors Curved 4 & 1/2 SharpFZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821114 | Operating Scissors Curved 6 & 1/2 SharpFZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821113 | Operating Scissors 5&1/2 Curved SharpFZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821112 | Conphar Scissors 4&1/2 Sharp BluntFZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K821111 | Conphar Scissors 4&AHALF SharpsharpFZT · Traditional | Conphar, Inc. | 05/07/1982SE |
| K820170 | Med-Care Emergency ShearsFZT · Traditional | Medcare Products | 02/05/1982SE |
| K801746 | Suture Removal PakFZT · Traditional | Devco Medical Industries, Inc. | 08/20/1980SE |
| K800103 | Surgical Stitch CutterFZT · Traditional | Macon & Co., Inc. | 01/28/1980SE |
| K791984 | Scissor's #'S 2294,2262,2263FZT · Traditional | Edward Weck, Inc. | 10/17/1979SE |
| K791742 | Brooks Gall Bladder Scissors (Surg)FZT · Traditional | Edward Weck, Inc. | 10/04/1979SE |
| K791741 | Floor Line InstrumentsFZT · Traditional | Edward Weck, Inc. | 10/04/1979SE |
| K791734 | Surgical Instruments Heifetz DigitateFZT · Traditional | Edward Weck, Inc. | 09/12/1979SE |
| K790684 | Color Coding of Surgical InstrumentsFZT · Traditional | Sara Dan, Inc. | 05/18/1979SE |
| K790491 | Itimized InstrumentsFZT · Traditional | E.M. Adams | 04/04/1979SE |
| K780574 | Suture CutterFZT · Traditional | Laschal Instrument Corp. | 07/17/1978SE |
| K780575 | Laschal ScissorFZT · Traditional | Laschal Instrument Corp. | 04/18/1978SE |
| K780152 | Facelift ScissorsFZT · Traditional | Edward Weck, Inc. | 02/02/1978SE |
| K772301 | Laparoscopy Drape, BoundaryFZT · Traditional | Procter & Gamble Mfg. Co. | 12/20/1977SE |
| K771806 | Thorek Scissors 7 1/4 & 10FZT · Traditional | J. Sklar Mfg. Co., Inc. | 10/04/1977SE |
| K771743 | Surg. Scissors for Cutting TissueFZT · Traditional | Depuy, Inc. | 09/26/1977SE |
| K770544 | Scissors, Bandage, 15,18,20CM., AngularFZT · Traditional | Sea-Pac Trading Corp. | 04/15/1977SE |
| K770543 | Scissors, Surgical, Angular, 14 Cm.FZT · Traditional | Sea-Pac Trading Corp. | 04/15/1977SE |
| K770542 | Scissors, Mayo _Tyle, 14,16,18,20,22 Cm.FZT · Traditional | Sea-Pac Trading Corp. | 04/15/1977SE |
| K770541 | Scissors, Surgical, 12.5,14,16 & 18 Cm.FZT · Traditional | Sea-Pac Trading Corp. | 04/15/1977SE |
| K770305 | Cutter, P607 BoneFZT · Traditional | Dentronix, Inc. | 03/09/1977SE |
| K770304 | Cutter, P605 General PurposeFZT · Traditional | Dentronix, Inc. | 03/09/1977SE |
| K770303 | Nipper, Nail, P610 EnglishFZT · Traditional | Dentronix, Inc. | 03/09/1977SE |
| K770302 | Cutter, P606 BoneFZT · Traditional | Dentronix, Inc. | 03/09/1977SE |
| K770301 | Nipper, PSO4 TissueFZT · Traditional | Dentronix, Inc. | 03/07/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0932-2025 Class II | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75"…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-1222-2011 | Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071…Pouch integrity may be compromised, resulting in loss of sterility. | Maquet Cardiovascular | 06/04/2010Terminated |
| Z-2164-2008 | FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B…The firm discovered a component production issue which may cause the cartridge to deploy an incomplete… | Ethicon Endo-Surgery Inc | 04/24/2008Terminated |
| Z-2163-2008 | ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during…The firm discovered a component production issue which may cause the cartridge to deploy an incomplete… | Ethicon Endo-Surgery Inc | 04/24/2008Terminated |
| Z-2162-2008 | ENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized during general, gynecologic…The firm discovered a component production issue which may cause the cartridge to deploy an incomplete… | Ethicon Endo-Surgery Inc | 04/24/2008Terminated |
| Z-2161-2008 | ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic…The firm discovered a component production issue which may cause the cartridge to deploy an incomplete… | Ethicon Endo-Surgery Inc | 04/24/2008Terminated |