510(k) K934094 ยท GCJ Laparoscope, General & Plastic Surgery
STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
| Applicant | Stryker Corp., San Jose CA, US |
| Decision | Substantially Equivalent, Feb 18, 1994 |
| Received | Aug 23, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934094
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2025 | Stryker Corporation Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip Open, Classified |
GCJ | None listed |
| Sep 12, 2019 | Stryker Corporation Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926
This products was distributed with the following sheath/probe:
0250 Terminated |
GEI | None listed |
| Nov 17, 2017 | Stryker Corporation StrykeFlow 2 System, labeled sterile. Includes the following:
a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500);
b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposabl Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.