K212786 is an FDA 510(k) clearance for the LevaLap Laparoscopic Access Device. This device is classified as a Insufflator, Laparoscopic (Class II - Special Controls, product code HIF).
Submitted by Core Access Surgical Technologies, Inc. (Atlanta, US). The FDA issued a Cleared decision on February 23, 2022, 175 days after receiving the submission on September 1, 2021.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1730.
| 510(k) Number | K212786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 2021 |
| Decision Date | February 23, 2022 |
| Days to Decision | 175 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 |