Cleared Traditional

K063713 - AMS SMART SLING SYSTEM

K063713 is an FDA 510(k) clearance for AMS SMART SLING SYSTEM, manufactured by American Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code OTN cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K063713 · American Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
70d
Days
Class 2
Risk

K063713 is an FDA 510(k) clearance for the AMS SMART 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 February 22, 2007 after a review of 70 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 American Medical Systems, Inc. devices

FDA 510(k) Submission Details - K063713

510(k) Number K063713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2006
Decision Date February 22, 2007
Days to Decision 70 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
61d faster than avg
Panel avg: 131d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OTN Device Classification - Class 2, Special Controls

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 52
Devices cleared under the same product code (OTN) and FDA review panel - the closest regulatory comparables to K063713.
SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
K081613 · American Medical Systems, Inc. · Sep 2008
DESARA MESH SLING, MODEL CAL-DS01
K072456 · Caldera Medical, Inc. · May 2008
ALIGN URETHRAL SUPPORT SYSTEM
K070073 · C.R. Bard, Inc. · Mar 2007
T-SLING
K050516 · Herniamesh S.R.L. · Feb 2006
I-STOP
K051533 · Cl Medical · Aug 2005
MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193
K051530 · American Medical Systems, Inc. · Jul 2005