Apyx
510(k) K230730
Apyx is a Class II device made by Escala Medical, cleared under FDA 510(k) K230730 on 25 Jul 2023, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK230730 | Date25 Jul 2023 | StatusActive |
Official records
- FDA 510(k) database K230730
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PBQ
- Device class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K230730
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Mendit Single Applicator Set | ES0647 / Mendit Single Applicator Set - Resorbable suture (PDS USP 2-0) | 07290019174431 | — | On the market |
| Mendit Single Applicator Set | ES0654 / Mendit Single Applicator Set -- permanent suture (ePTFE USP 0) | 07290019174448 | — | On the market |
| Mendit Single Applicator Set | ES0655 / Mendit Single Applicator Set - Resorbable suture (PDS USP 0) | 07290019174219 | — | On the market |
| Mendit Single Applicator Set | ES0656 / Mendit Single Applicator Set - Permanent suture (Prolene USP 2-0) | 07290019174226 | — | On the market |
| Mendit Single Applicator Set | ES0657 / Mendit Single Applicator Set - permanent suture (Prolene USP 0) | 07290019174233 | — | On the market |
| Mendit Single Applicator Set | ES0658 / Mendit Single Applicator Set - permanent suture (ePTFE USP 2-0) | 07290019174240 | — | On the market |
Similar devices
Other devices filed under FDA product code PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic Use).