Mendit
510(k) K260380
Mendit is a Class II device made by Escala Medical Ltd, cleared under FDA 510(k) K260380 on 4 Mar 2026, active as of 12 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 | NumberK260380 | Date4 Mar 2026 | StatusActive |
Official records
- FDA 510(k) database K260380
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PBQ
- FDA applicant
- Escala Medical, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 884.4530
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic Use).