AMS Large Pore Polypropylene Mesh
by American Medical Systems, Inc.
510(k) K033636
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033636 | Date31 Dec 2003 | StatusActive |
Official records
- FDA 510(k) database K033636
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OTP
- Device class
- Class III
- Regulation
- 21 CFR Part 884.5980
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The AMS Large Pore Polypropylene Mesh is a synthetic, urogynecologic surgical mesh designed for transvaginal placement. Classified as a Class III device under FDA regulations, it is intended for pelvic organ prolapse repair, providing mechanical support or bridging for fascial defects in vaginal wall prolapse cases. Constructed from knitted polypropylene fibers, the mesh reinforces and stabilizes pelvic floor structures to prevent recurrence of prolapse.
This device is supplied sterile and intended for single-use in surgical settings. It is regulated under FDA 510(k) clearance (K033636) and falls under the Obstetrics/Gynecology specialty category. Available in specified sizes, the mesh requires proper handling and implantation techniques as outlined in surgical guidelines. Storage must adhere to manufacturer instructions to maintain sterility and integrity prior to use.