510(k) K063367 ยท HIF Insufflator, Laparoscopic
45L CORE INSUFFLATOR, MODEL F114
| Applicant | W.O.M. World of Medicine AG, Cambridge MA, US |
| Decision | Substantially Equivalent, May 23, 2007 |
| Received | Nov 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2019 | Stryker Corporation Stryker High Flow II Tube Set, REF 0620-040-660, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile. Terminated |
HIF | None listed |
| Mar 7, 2019 | Stryker Corporation Stryker High Flow Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-680, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile. Terminated |
HIF | None listed |
| Mar 28, 2016 | Stryker Endoscopy PneumoSure XL High Flow Insufflator and PneumoSure High Flow Insufflator;
High pressure units (HPU) (40L and 45L).
Model Numbers: 620-040-610, 620-040-611, 620-040-613, 620-040-614, 620-040-600, 62 Terminated |
HIF | None listed |
| Mar 23, 2010 | Stryker Endoscopy Pnemosure Insufflators, model numbers 620-040-600 and 620-040-610, manufactured by Stryker Endoscopy, San Jose, CA. Terminated |
HIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.