Apyx
510(k) K213783
Apyx is a Class II device made by Escala Medical, cleared under FDA 510(k) K213783 on 5 Apr 2022, active as of 11 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 | NumberK213783 | Date5 Apr 2022 | StatusActive |
Official records
- FDA 510(k) database K213783
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- Withdrawn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 K213783
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 | |||
|---|---|---|---|---|
| APYX Applicator Set Resorbable Suture | ES0148 / APYX Applicator Set Resorbable Suture | 07290019174066 | On the market | |
| Apyx Retriever Set Resorbable Suture | ES0149 / Apyx Retriever Set Resorbable Suture | 07290019174011 | On the market | |
| Mendit Applicator Set | ES0154 / Mendit Applicator Set - Permanent suture ( Polypropylene USP 2-0) | 07290019174035 | On the market | |
| Mendit applicator set | ES0510 / Mendit applicator set - permanent suture (ePTFE 2-0) | 07290019174097 | On the market | |
| Mendit Applicator Set | ES0515 / Mendit Applicator Set -permanent suture (ePTFE USP 0) | 07290019174127 | On the market | |
| Mendit Applicator Set | ES0523 / Mendit Applicator Set - permanent suture (Polypropylene USP 0) | 07290019174134 | On the market | |
| Mendit Applicator Set | ES0528 / Mendit Applicator Set - Absorbable suture (PDS,Polydioxanone USP 0) | 07290019174158 | On the market | |
| Mendit Reload Set | ES0322 / Mendit Reload Set – Permanent Suture (Polypropylene USP 2-0) | 07290019174059 | On the market | |
| Mendit Reload Set | ES0511 / Mendit Reload Set - Permanent Suture (ePTFE 2-0) | 07290019174103 | On the market | |
| Mendit Reload Set | ES0516 / Mendit Reload Set – Permanent Suture (ePTFE USP 0) | 07290019174110 | On the market | |
| Mendit Reload Set | ES0524 / Mendit Reload Set – Permanent Suture (Polypropylene USP 0) | 07290019174141 | On the market | |
| Mendit Reload Set | ES0529 / Mendit Reload Set –Absorbable Suture (PDS,Polydioxanone USP 0) | 07290019174165 | On the market | |
| Mendit Reload Set – Resorbable Suture | ES0321 / Mendit Reload Set – Resorbable Suture | 07290019174028 | On the market | |
| Mendit Retriever Set | ES0155 / Mendit Retriever set - Permanent suture (Polypropylene USP 2-0) | 07290019174042 | On the market | |
| Mendit Retriever Set | ES0512 / Mendit Retriever Set - permanent suture (ePTFE 2-0) | 07290019174196 | On the market | |
| Mendit Retriever Set | ES0517 / Mendit Retriever Set - permanent suture (ePTFE USP 0) | 07290019174202 | On the market | |
| Mendit Retriever Set | ES0525 / Mendit Retriever Set - permanent suture (Polypropylene USP 0) | 07290019174189 | On the market | |
| Mendit Retriever Set | ES0530 / Mendit Retriever Set - Absorbable suture (PDS,Polydioxanone USP 0) | 07290019174172 | On the market |
Similar devices
Other devices filed under FDA product code PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic Use).