510(k) K003792 ยท HIF Insufflator, Laparoscopic
STRYKER HEATED INSUFFLATOR TUBE SET
| Applicant | Stryker Corp., Santa Clara CA, US |
| Decision | Substantially Equivalent, Feb 21, 2001 |
| Received | Dec 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003792
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2019 | Stryker Corporation Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile. Terminated |
HIF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.