Cleared Traditional

K070073 - ALIGN URETHRAL SUPPORT SYSTEM

K070073 is the FDA 510(k) clearance for ALIGN URETHRAL SUPPORT SYSTEM by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OTN) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K070073 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
72d
Days
Class 2
Risk

K070073 is an FDA 510(k) clearance for the ALIGN URETHRAL SUPPORT SYSTEM. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on March 21, 2007 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K070073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2007
Decision Date March 21, 2007
Days to Decision 72 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 130d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Surgical Treatment Of Female Stress Urinary Incontinence Due To Intrinsic Sphincter Deficiency (isd) And/or Urethral Hypermobility
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

All 35
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K070073.
ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
K093747 · C.R. Bard, Inc. · May 2010
GYNECARE TVT EXACT CONTINENCE SYSTEM
K100485 · Ethicon, Inc. · Mar 2010
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
K081613 · American Medical Systems, Inc. · Sep 2008
AMS SMART SLING SYSTEM
K063713 · American Medical Systems, Inc. · Feb 2007
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193
K051530 · American Medical Systems, Inc. · Jul 2005
INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
K042592 · American Medical Systems, Inc. · Dec 2004