K243527 is an FDA 510(k) clearance for the High Flow Insufflation Unit (UHI-4), a Insufflator, Laparoscopic (Class II — Special Controls, product code HIF), submitted by Olympus Medical Systems Corporation (Hachiochi-Shi, JP). The FDA issued a Cleared decision on January 13, 2025, 60 days after receiving the submission on November 14, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K243527 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 14, 2024 |
| Decision Date | January 13, 2025 |
| Days to Decision | 60 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 |