K193520 is an FDA 510(k) clearance for the EVA 15 Insufflator. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Palliare , Ltd. (Galway, IE). The FDA issued a Cleared decision on July 23, 2020, 217 days after receiving the submission on December 19, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K193520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 19, 2019 |
| Decision Date | July 23, 2020 |
| Days to Decision | 217 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 |