Cleared Special

K070065 - AMS SINGLE INCISION SLING SYSTEM (SIS-0)

K070065 is an FDA 510(k) clearance for AMS SINGLE INCISION SLING SYSTEM (SIS-0), manufactured by American Medical Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PAH cleared through the Special 510(k) pathway after a 52-day FDA review.

K070065 · American Medical Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
52d
Days
Class 2
Risk

K070065 is an FDA 510(k) clearance for the AMS SINGLE INCISION SLING SYSTEM (SIS-0). Classified as Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling (product code PAH), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on March 1, 2007 after a review of 52 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.

FDA 510(k) Submission Details - K070065

510(k) Number K070065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2007
Decision Date March 01, 2007
Days to Decision 52 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
79d faster than avg
Panel avg: 131d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

PAH Device Classification - Class 2, Special Controls

Product Code PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.3300
Definition Transvaginal Surgical Repair Of Female Stress Urinary Incontinence (sui) 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 - PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling

All 19
Devices cleared under the same product code (PAH) and FDA review panel - the closest regulatory comparables to K070065.
MINITAPE URETHRAL SLING
K073646 · Mpathy Medical Devices, Ltd. · Feb 2008
AMS MINIARC SLING SYSTEM
K073703 · American Medical Systems, Inc. · Jan 2008
AMS MINIARC SLING SYSTEM
K071902 · American Medical Systems, Inc. · Aug 2007
NEEDLELESS SLING
K063136 · Specialities Remeex International, S.L. · Dec 2006
GYNECARE TVT SECUR SYSTEM
K052401 · Ethicon, Inc. · Nov 2005
GYNE IDEAS MINITAPE RP DEVICE
K023898 · Gyne Ideas , Ltd. · Jun 2003
K070065 · AMS SINGLE INCISION SLING SYSTEM (SIS-0)
Download PDF FDA Summary American Medical Syst…