K140263 is an FDA 510(k) clearance for the INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT. 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 March 5, 2014, 30 days after receiving the submission on February 3, 2014.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K140263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2014 |
| Decision Date | March 05, 2014 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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 |