K030837 is an FDA 510(k) clearance for the 40 L HIGH FLOW INSUFFLATOR F108. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by W.O.M. World of Medicine AG (Alexandria, US). The FDA issued a Cleared decision on February 5, 2004, 325 days after receiving the submission on March 17, 2003.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K030837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2003 |
| Decision Date | February 05, 2004 |
| Days to Decision | 325 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIF — Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |