K091366 is an FDA 510(k) clearance for the INSUFLOW DEWHEART. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Lexion Medical, LLC (St. Paul, US). The FDA issued a Cleared decision on September 3, 2009, 118 days after receiving the submission on May 8, 2009.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K091366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2009 |
| Decision Date | September 03, 2009 |
| Days to Decision | 118 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 |