510(k) K172040 ยท HIG Insufflator, Hysteroscopic
Aquilex Fluid Control System AQL-100S
| Applicant | W.O.M. World of Medicine GmbH, Berlin, DE |
| Decision | Substantially Equivalent, Feb 5, 2018 |
| Received | Jul 5, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K172040
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2024 | WOM World Of Medicine AG Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowi Open, Classified |
HIG | None listed |
| Aug 14, 2019 | WOM World of Medicine AG Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS
Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies. Terminated |
HIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.