510(k) K963646 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW
| Applicant | Stryker Endoscopy, Santa Clara CA, US |
| Decision | Substantially Equivalent, Apr 16, 1997 |
| Received | Sep 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963646
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2026 | Stryker Corporation STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 Open, Classified |
GEI | None listed |
| Aug 3, 2026 | Stryker Corporation STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 Open, Classified |
GEI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.