Elevate Prolapse Repair Systems-Apical Needle Passer Sheath Modification
510(k) K121612
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121612 | Date20 Jul 2012 | 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- Withdrawn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 APICAL Needle Passer Sheath Modification is a component of the Elevate Prolapse Repair System, designed for transvaginal urogynecologic procedures. It is intended for use in the repair of pelvic organ prolapse, facilitating the placement of synthetic mesh via an apical needle passer.
This modification is supplied as a single-use device, intended for sterile surgical use in an operating room setting. It is classified as a Class III medical device under FDA regulations and requires FDA 510(k) clearance. The device is part of a system approved for obstetrics/gynecology applications, with specific reference codes and registration numbers as documented in regulatory filings.
Other devices from American Medical Systems, Inc.
Questions
AI-generated answers, 18 Sep 2026
What specific surgical procedures is this APICAL Needle Passer Sheath Modification intended to assist with within the Elevate Prolapse Repair System?
This modification is designed specifically for transvaginal urogynecologic procedures, particularly to facilitate the placement of synthetic mesh during pelvic organ prolapse repairs. It is part of the Elevate Prolapse Repair System and is used to guide the needle passer during apical suspension, helping to secure the mesh in place for prolapse correction.
Is the APICAL Needle Passer Sheath Modification reusable or intended for single-use only, and how should it be handled in the operating room?
The device is explicitly supplied as a single-use item, intended for sterile surgical use in an operating room setting only. Since it is sterile and designed for one-time use, it must be opened and used immediately, then discarded after the procedure to maintain sterility and prevent cross-contamination.
What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians using it?
The device underwent an FDA 510(k) clearance process, specifically classified as Substantially Equivalent (SESE) under a Special Review by the Obstetrics/Gynecology (OB) Advisory Committee. This means the FDA determined it is as safe and effective as a legally marketed predicate device, ensuring it meets established standards for transvaginal pelvic organ prolapse repairs involving synthetic mesh placement.
How is this modification different from other components of the Elevate Prolapse Repair System, and why is it considered a separate modification?
This APICAL Needle Passer Sheath Modification is a specialized accessory within the Elevate Prolapse Repair System, specifically designed to improve the precision of apical needle passage during mesh placement. Unlike other system components, it is engineered to enhance the handling and accuracy of the needle passer, reducing potential trauma and improving surgical outcomes for pelvic organ prolapse cases.