Ams Elevate Pc
by American Medical Systems, Inc.
510(k) K112842
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK112842 | Date25 Oct 2011 | 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- Withdrawn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 Elevate PC Prolapse Repair System is a synthetic surgical mesh device designed for transvaginal placement in urogynecologic applications. Classified as a Class III device under FDA regulations, it is intended for use in correcting pelvic organ prolapse by providing structural support to the pelvic floor.
This system consists of an IntePro Lite surgical mesh assembly and non-implantable needle passers/surgical aids, supplied sterile for single-use in clinical settings. It is regulated under FDA 510(k) clearance (K112842) and falls under the product code OTP, with advisory committee review in Obstetrics/Gynecology. Storage and handling must comply with sterile surgical device protocols.
Other devices from American Medical Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the AMS Elevate PC primarily used for in clinical settings?
The AMS Elevate PC Prolapse Repair System is designed specifically for transvaginal placement to correct pelvic organ prolapse by providing structural support to the pelvic floor. It is intended for urogynecologic applications where synthetic mesh is needed to reinforce weakened pelvic tissues.
Is the AMS Elevate PC meant for single-use or can it be reused in multiple procedures?
The AMS Elevate PC is supplied sterile for single-use only in clinical settings. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety.
What components does the AMS Elevate PC system include, and are they all sterile?
The system includes an IntePro Lite surgical mesh assembly (sterile) and non-implantable needle passers/surgical aids (also sterile). The mesh is the implantable portion, while the needle passers are tools used during surgery and are not intended for implantation.
How should the AMS Elevate PC be stored to maintain its sterility?
Since it is a sterile surgical device, storage must follow standard sterile surgical device protocols. This typically includes keeping the packaging intact, sealed, and protected from contamination until immediate preoperative use.
What regulatory pathway was followed for FDA clearance of the AMS Elevate PC?
The AMS Elevate PC received FDA 510(k) clearance (K112842) under a Special 510(k) review process, classified as a Class III device for urogynecologic mesh applications. The submission was reviewed by the Obstetrics/Gynecology (OB) Advisory Committee and determined to be substantially equivalent to a predicate device.