K213783 is an FDA 510(k) clearance for the Apyx. This device is classified as a Fixation, Non-absorbable Or Absorbable, For Pelvic Use (Class II - Special Controls, product code PBQ).
Submitted by Escala Medical (Misgav Industrial Park, IL). The FDA issued a Cleared decision on April 5, 2022, 123 days after receiving the submission on December 3, 2021.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530. Attaching Suture Or Stapling Ligaments Of The Pelvic Floor..
| 510(k) Number | K213783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2021 |
| Decision Date | April 05, 2022 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PBQ - Fixation, Non-absorbable Or Absorbable, For Pelvic Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
| Definition | Attaching Suture Or Stapling Ligaments Of The Pelvic Floor. |