Cleared Traditional

K090739 - BARD SACROCOLPOPEXY GRAFT

K090739 is the FDA 510(k) clearance for BARD SACROCOLPOPEXY GRAFT by C.R. Bard, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code OTO) cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K090739 · C.R. Bard, Inc. · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
Nov 2009
Decision
235d
Days
Class 2
Risk

K090739 is an FDA 510(k) clearance for the BARD SACROCOLPOPEXY GRAFT. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (product code OTO), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on November 10, 2009 after a review of 235 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 878.3300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K090739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2009
Decision Date November 10, 2009
Days to Decision 235 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 160d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

All 12
Devices cleared under the same product code (OTO) and FDA review panel - the closest regulatory comparables to K090739.
ARTISYN Y-SHAPED MESH
K113205 · Ethicon, Inc. · Jun 2012
RESTORELLE POLYPROPYLENE Y MESH
K112322 · Coloplast A/S · May 2012
ALYTE Y-MESH GRAFT
K101722 · C.R. Bard, Inc. · Apr 2011
AMS PELVIC FLOOR REPAIR SYSTEM
K051485 · American Medical Systems, Inc. · Aug 2005
AMS SACRAL COLPOPEXY SLING, MODEL 72403501
K010931 · American Medical Systems, Inc. · Apr 2001