510(k) K170784 ยท HIF Insufflator, Laparoscopic
PNEUMOCLEAR
| Applicant | W.O.M. World of Medicine GmbH, Berlin, DE |
| Decision | Substantially Equivalent, May 15, 2017 |
| Received | Mar 15, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170784
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2018 | WOM World of Medicine AG PNEUMOCLEAR Heated High-Flow Tube Set
Product Usage:
The Heated High-Flow Tube Set is a single use sterile tube set used in combination with the PNEUMOCLEAR C02 insufflator as a separate accessory. Terminated |
HIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.