Cleared Special

K021263 - MODIFICATION TO SPARC SLING SYSTEM

K021263 is the FDA 510(k) clearance for MODIFICATION TO SPARC SLING SYSTEM 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 23-day FDA review.

K021263 · American Medical Systems, Inc. · Gastroenterology & Urology device
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May 2002
Decision
23d
Days
Class 2
Risk

K021263 is an FDA 510(k) clearance for the MODIFICATION TO SPARC SLING SYSTEM. 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 May 15, 2002 after a review of 23 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 K021263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2002
Decision Date May 15, 2002
Days to Decision 23 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
107d faster than avg
Panel avg: 130d · This submission: 23d
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 K021263.
MENTOR OBTAPE TRANS-OBTURATOR TAPE
K031767 · Mentor Corp. · Jul 2003
BIOARC SP SLING KIT
K030123 · American Medical Systems, Inc. · Feb 2003
MONARC SLING SYSTEM
K023516 · American Medical Systems, Inc. · Nov 2002
MODIFICATION TO TRELEX MESH SURGICAL MESH
K020110 · Boston Scientific · Apr 2002
MODIFICATION TO SPARC SLING SYSTEM
K020663 · American Medical Systems, Inc. · Mar 2002
SPARC SLING SYSTEM
K013355 · American Medical Systems, Inc. · Oct 2001