Cleared Special

K093747 - ALIGN AND ALIGN TO URETHRAL SUPPORT SYS...

K093747 is the FDA 510(k) clearance for ALIGN AND ALIGN TO URETHRAL SUPPORT SYS... by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OTN) cleared through the Special 510(k) pathway after a 154-day FDA review.

K093747 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
154d
Days
Class 2
Risk

K093747 is an FDA 510(k) clearance for the ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS. 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 May 7, 2010 after a review of 154 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 878.3300 - the FDA gastroenterology and urology 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K093747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2009
Decision Date May 07, 2010
Days to Decision 154 days
Submission Type Special
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
24d slower than avg
Panel avg: 130d · This submission: 154d
Pathway characteristics
Modification to existing cleared device.

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 33
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K093747.
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K121754 · Boston Scientific Corp · Oct 2012
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K100485 · Ethicon, Inc. · Mar 2010
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
K081613 · American Medical Systems, Inc. · Sep 2008
ALIGN URETHRAL SUPPORT SYSTEM
K070073 · C.R. Bard, Inc. · Mar 2007