Upsylon Y Mesh
510(k) K122794
Upsylon Y Mesh is a Class II device made by Boston Scientific, cleared under FDA 510(k) K122794 on 18 Dec 2012, active as of 22 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 | NumberK122794 | Date18 Dec 2012 | StatusActive |
Official records
- FDA 510(k) database K122794
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OTO
- FDA applicant
- Boston Scientific Corp
- 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).
- Modification to: Minimesh Polypropylene Mesh by Mpathy Medical Devices, Ltd.
- AMS Sacral Colpopexy Sling, Model 72403501 by AMERICAN MEDICAL SYSTEMS, INC.
- 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.
- RESTORELLE L by Coloplast Corp.
- RESTORELLE M, RESTORELLE XL by Coloplast Corp.