510(k) K173489 ยท HIG Insufflator, Hysteroscopic
GYN-Pump PH304
| Applicant | W.O.M. World of Medicine GmbH, Berlin, DE |
| Decision | Substantially Equivalent, Mar 28, 2018 |
| Received | Nov 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173489
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2021 | WOM World of Medicine AG Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000 Open, Classified |
HIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.