510(k) K914910 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
DAVOL LAPAROSCOPIC INSTRUMENTS (GEN SURG REUSABLE)
| Applicant | Davol, Inc., Cranston RI, US |
| Decision | Substantially Equivalent, Jan 6, 1992 |
| Received | Nov 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914910
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5860020. Open, Classified |
GEI | None listed |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030. Open, Classified |
GEI | None listed |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100. Open, Classified |
GEI | None listed |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Sharp Tooth Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863020. Open, Classified |
GEI | None listed |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030. Open, Classified |
GEI | None listed |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Alligator Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863050. Open, Classified |
GEI | None listed |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5864000. Open, Classified |
GEI | None listed |
| Jun 2, 2025 | Silex Medical, LLC Signature Laparoscopic Instruments, 20mm Atraumatic Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5881033. Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.