Cleared Special

K040538 - BIOARC SP SLING KIT AND BIOARC TO SLING...

K040538 is the FDA 510(k) clearance for BIOARC SP SLING KIT AND BIOARC TO SLING... by American Medical Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code OTN) cleared through the Special 510(k) pathway after a 15-day FDA review.

K040538 · American Medical Systems, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
15d
Days
Class 2
Risk

K040538 is an FDA 510(k) clearance for the BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996. Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (product code OTN), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on March 17, 2004 after a review of 15 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. 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 K040538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2004
Decision Date March 17, 2004
Days to Decision 15 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
115d faster than avg
Panel avg: 130d · This submission: 15d
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 35
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K040538.
SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS
K041948 · American Medical Systems, Inc. · Aug 2004
URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
K041176 · Sofradim Production · May 2004
MODIFICATION TO SURGICAL MESH POLYMERIC
K040787 · Boston Scientific · Apr 2004
GYNECARE TVT OBTURATOR SYSTEM
K033568 · Ethicon, Inc. · Dec 2003
MENTOR OBTAPE TRANS-OBTURATOR TAPE
K031767 · Mentor Corp. · Jul 2003
BIOARC SP SLING KIT
K030123 · American Medical Systems, Inc. · Feb 2003