K190303 is an FDA 510(k) clearance for the AirSeal. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on March 28, 2019, 44 days after receiving the submission on February 12, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K190303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2019 |
| Decision Date | March 28, 2019 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HIF — Insufflator, Laparoscopic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.1730 |