Cleared Special

K010931 - AMS SACRAL COLPOPEXY SLING, MODEL 72403501 (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K010931 · American Medical Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
12d
Days
Class 2
Risk

K010931 is an FDA 510(k) clearance for the AMS SACRAL COLPOPEXY SLING, MODEL 72403501. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (product code OTO), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on April 9, 2001 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 878.3300 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all American Medical Systems, Inc. devices

Submission Details

510(k) Number K010931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2001
Decision Date April 09, 2001
Days to Decision 12 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d faster than avg
Panel avg: 160d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Bridging Material To Attach The Vaginal Apex To The Anterior Longitudinal Ligament Of The Sacrum; Procedures Include Abdominal Sacrocolpopexy And Laparoscopic Sacrocolpopexy.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.