K153513 is an FDA 510(k) clearance for the Insufflator 50L FM134. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on March 4, 2016, 88 days after receiving the submission on December 7, 2015.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K153513 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2015 |
| Decision Date | March 04, 2016 |
| Days to Decision | 88 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 |