K242772 is an FDA 510(k) clearance for the AirSurgN Insufflator (10030/AirSurgN), a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by Smartsurgn, Inc. (San Jose, US). The FDA issued a Cleared decision on April 11, 2025, 210 days after receiving the submission on September 13, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K242772 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 13, 2024 |
| Decision Date | April 11, 2025 |
| Days to Decision | 210 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 |