510(k) K971022 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
CHASE SUCKER
| Applicant | Chase Medical, Inc., Richardson TX, US |
| Decision | Substantially Equivalent, Apr 17, 1997 |
| Received | Mar 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971022
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 31, 2024 | Med Michigan Holding Llc SUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm) length. Indicated for handheld use only to remove excess fluid from the surgical field. Open, Classified |
GCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.