Mendit Reload Set – Resorbable Suture
Mendit Reload Set – Resorbable Suture (ES0321) is a Class II device made by Escala Medical, cleared under FDA 510(k) K213783 on 5 Apr 2022 and listed in FDA GUDID since 25 Jun 2023 (UDI-DI 07290019174028), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290019174028 | Date25 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213783 | Date5 Apr 2022 | StatusActive |
Official records
- AccessGUDID record 07290019174028
- FDA 510(k) database K213783
Across registries
- FDA 510(k) K213783 decided 5 Apr 2022 Active
- FDA GUDID UDI-DI 07290019174028 listed 25 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K213783
- Listed FDA GUDID 07290019174028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Mendit Reload Set
- Generic name
- Soft-tissue/mesh anchor, bioabsorbable
- Model / Ref / Catalog
- Mendit Reload Set – Resorbable Suture, ES0321
- Primary DI / UDI-DI
- 07290019174028
- 510(k) Number
- FDA product code
- PBQ
- GMDN term
- Soft-tissue/mesh anchor, bioabsorbable
- Device class
- Class II
- Regulation number
- 884.4530
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
- MRI safety
- MR Conditional
Similar devices
Other devices filed under FDA product code PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic Use).