510(k) K963765 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
STRYKER STRYKEFLOW ELECTROCAUTERY PROBES
| Applicant | Stryker Endoscopy, Santa Clara CA, US |
| Decision | Substantially Equivalent, Jan 31, 1997 |
| Received | Sep 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963765
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2019 | Stryker Corporation Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971
These products are distributed with the following sheath/probe:
025 Terminated |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.