AMS Perigee System
by American Medical Systems, Inc.
510(k) K040623
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK040623 | Date17 May 2004 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
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- Withdrawn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, 18 Sep 2026
The AMS Perigee System is a synthetic urogynecologic mesh device designed for transvaginal placement in the treatment of pelvic organ prolapse, specifically anterior vaginal wall prolapse. Classified as a surgical mesh under FDA device code OTP, it is intended for use in obstetrics and gynecology procedures to support vaginal tissue and restore anatomical function.
This system is supplied as a surgical instrument kit, including needles and connectors for mesh graft placement via the obturator foramen. It is intended for single-use in clinical or operating room settings and is regulated under 21 CFR 884.5980. The device received FDA 510(k) clearance in 2004, with a classification as a Class III device, and is distributed by American Medical Systems, Inc.
Other devices from American Medical Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
What specific type of pelvic organ prolapse is the AMS Perigee System designed to treat, and how is it placed in the body?
The AMS Perigee System is specifically designed for treating anterior vaginal wall prolapse, a type of pelvic organ prolapse where the front wall of the vagina sags into the vaginal canal. It is placed transvaginally using a surgical instrument kit that includes needles and connectors, allowing the mesh graft to be secured via the obturator foramen to support the vaginal tissue and restore anatomical function.
Is the AMS Perigee System intended for reuse in clinical settings, and if not, why?
No, the AMS Perigee System is intended for single-use only in clinical or operating room settings. This is explicitly stated in the device description, ensuring patient safety and sterility for each procedure.
What regulatory pathway did the AMS Perigee System follow to gain FDA clearance, and what classification does it hold?
The AMS Perigee System received FDA 510(k) clearance through a Traditional review pathway, with a classification as a Class III device. It was determined to be Substantially Equivalent (SE) to a predicate device and is regulated under 21 CFR 884.5980, reflecting its status as a surgical mesh for urogynecologic use.
How is the AMS Perigee System supplied, and what components are included in the surgical kit?
The AMS Perigee System is supplied as a surgical instrument kit, which includes needles and connectors specifically designed for mesh graft placement via the obturator foramen. This setup facilitates precise transvaginal placement of the synthetic mesh for pelvic organ prolapse support.