K122180 is an FDA 510(k) clearance for the HIGH FLOW INSUFFLANTION UNIT. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on November 13, 2012, 113 days after receiving the submission on July 23, 2012.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K122180 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2012 |
| Decision Date | November 13, 2012 |
| Days to Decision | 113 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 |