K201361 is an FDA 510(k) clearance for the PNEUMOCLEAR. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on July 29, 2020, 68 days after receiving the submission on May 22, 2020.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K201361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2020 |
| Decision Date | July 29, 2020 |
| Days to Decision | 68 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 |