Carrier, Ligature
FDA product code GEJ · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
5510(k) clearances
0PMA approvals
4recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240185 | Cypris eXact Suture Placement DeviceGEJ · Traditional | Cypris Medical | 05/03/2024SE |
| K900959 | GS-1400 Toothed Dissecting Forcep, 5MM, InsulatedGEJ · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K900958 | GS-1300 Atraumatic Grasping Forcep, Curved, 10MMGEJ · Traditional | Solos Endoscopy, Inc. | 04/18/1990SE |
| K884553 | Stamey NeedleGEJ · Traditional | Cook Ob/Gyn | 11/14/1988SE |
| K874342 | Ligature Carrier/Packer, HydroxylapatiteGEJ · Traditional | Cox-Uphuff Intl. | 11/13/1987SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2536-2017 Class II | Stamey Needlereprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and… | Cook Inc. | 04/25/2017Terminated |
| Z-2535-2017 Class II | Pereyra Ligature Carrier 75reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and… | Cook Inc. | 04/25/2017Terminated |
| Z-2534-2017 Class II | Pereyra-Raz Ligature Carrierreprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and… | Cook Inc. | 04/25/2017Terminated |
| Z-0096-2007 | ConMed Laparoscopic Instrument: Babcock Disposable Grasper, 5mm x 43cm length…The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube. | Conmed Corporation | 10/12/2006Terminated |