Restorelle L
510(k) K122440
Restorelle L is a Class II device made by Coloplast Corp., cleared under FDA 510(k) K122440 on 19 Nov 2012, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK122440 | Date19 Nov 2012 | StatusActive |
Official records
- FDA 510(k) database K122440
Recalls
-
- Terminated Z-1341-2013
Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.
Timeline
- Cleared FDA 510(k) K122440
- Recall initiated FDA recalls Z-1341-2013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OTO
- Device class
- Class II
- Regulation
- 21 CFR Part 878.3300
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed).
- UPSYLON Y MESH by Boston Scientific
- GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR by Gynecare, A Div. of Ethicon, Inc.
- POLYFORM SYNTHETIC MESH by Proxy Biomedical, Ltd.
- VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM by CALDERA MEDICAL, INC.
- AMS LARGE PORE POLYPROPHLENE MESH by AMERICAN MEDICAL SYSTEMS, INC.
- RESTORELLE Y CONTOUR by Coloplast A/S
- VERTESSA by CALDERA MEDICAL, INC.
- BARD SACROCOLPOPEXY GRAFT by C. R. Bard, Inc.
- AMS PELVIC FLOOR REPAIR SYSTEM by AMERICAN MEDICAL SYSTEMS, INC.
- RESTORELLE Y CONTOUR MESH by Coloplast A/S