K063367 is an FDA 510(k) clearance for the 45L CORE INSUFFLATOR, MODEL F114. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by W.O.M. World of Medicine AG (Cambridge, US). The FDA issued a Cleared decision on May 23, 2007, 197 days after receiving the submission on November 7, 2006.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K063367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 2006 |
| Decision Date | May 23, 2007 |
| Days to Decision | 197 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 |