Panels › General, Plastic Surgery › Product code FZT · Class 1
Cutter, Surgical
Regulation 878.4800
0510(k)s in 12 months (52 all time)
0recalls in 12 months (6 all time)
4recalls that name a 510(k)
Top companies in FZT
| Company | 510(k)s | Recalls |
|---|---|---|
| Conphar, Inc. | 21 | 0 |
| Dentronix, Inc. | 5 | 0 |
| Edward Weck, Inc. | 5 | 0 |
| Ethicon Endo-Surgery Inc | 0 | 4 |
| Sea-Pac Trading Corp. | 4 | 0 |
| J. Sklar Mfg. Co., Inc. | 2 | 0 |
| Laschal Instrument Corp. | 2 | 0 |
| Depuy, Inc. | 1 | 0 |
| Devco Medical Industries, Inc. | 1 | 0 |
| E.M. Adams | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 16, 2025 | Sklar Instruments ECONO STERILE medical procedure kits labeled as:
1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A;
2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427;
3) ECO Open, Classified |
FZT | None listed |
| Feb 11, 2011 | Maquet Cardiovascular Maquet HEARTSTRING Aortic Cutter 4.3 mm, AC-3043, Lot numbers 9081071 and 9082071, Manufactured by Maquet Cardiovascular, Wayne, New Jersey.
Intended for use by cardiac surgeons during CABG procedure Terminated |
FZT | None listed |
| Aug 25, 2008 | Ethicon Endo-Surgery Inc FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S.
Utilized during general, gynecologic, urologic, and thoracic surgery for Terminated |
FZT | K020779 |
| Aug 25, 2008 | Ethicon Endo-Surgery Inc ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W.
Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. Terminated |
FZT | K020779 |
| Aug 25, 2008 | Ethicon Endo-Surgery Inc ENDOPATHETS Endoscopic Linear Cutter, TSW35.
Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. Terminated |
FZT | K020779 |
| Aug 25, 2008 | Ethicon Endo-Surgery Inc ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35
Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses. Terminated |
FZT | K020779 |
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