510(k) K954726 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
| Applicant | Stryker Endoscopy, Santa Clara CA, US |
| Decision | Substantially Equivalent, Nov 29, 1995 |
| Received | Aug 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954726
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2025 | Stryker Corporation Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip Open, Classified |
GCX | 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 |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 32cm Regular Tip, Vented, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 32cm Regular Tip, Vented, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
10mm X 32cm Pool Suction Tip, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 32cm Tip Hydrodissection Tip, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 45cm Regular Tip, Vented, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 32cm Regular Tip , Non-Vented, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 24cm Regular Tip, Vented, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 32cm Aspiration Needle Tip.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
2mm X 32cm Regular Tip with 1 Hole, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
2mm X 32cm Regular Tip with 2 Hole, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
2mm X 34cm Regular Tip with No Hole, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 28cm Regular Tip, vented, Non-Reflective Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 32cm Regular Tip, vented, Non-Reflective Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
10mm X 32cm Regular Tip, vented, Non-Reflective Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 32cm Hydrodissection Tip, Non-Reflective Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 45cm Regular Tip, vented, Non-Reflective Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
Vented Tip, 5mm X 45cm Non-Reflective with 30 Downward Bend At Proximal End.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscop Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
3mm X 32cm Regular Tip, Vented, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
| May 3, 2013 | Stryker Endoscopy Stryker Irrigator Reusable Tips:
3mm X 32cm Regular Tip, Non-Vented, Metal Finish.
Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Terminated |
GCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.