Cleared Traditional

K010990 - AMS SLING FIXATION SYSTEM

K010990 is an FDA 510(k) clearance for AMS SLING FIXATION SYSTEM, manufactured by American Medical Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K010990 · American Medical Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
80d
Days
Class 2
Risk

K010990 is an FDA 510(k) clearance for the AMS SLING FIXATION SYSTEM. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by American Medical Systems, Inc. (Minnetonka, US). The FDA issued a Cleared decision on June 22, 2001 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5010 - the FDA general and plastic surgery 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.

FDA 510(k) Submission Details - K010990

510(k) Number K010990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2001
Decision Date June 22, 2001
Days to Decision 80 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAW Device Classification - Class 2, Special Controls

Product Code GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5010
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAW Suture, Nonabsorbable, Synthetic, Polypropylene

All 84
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K010990.
SERRALENE, MODEL CATALOG NO 1S
K020265 · Serral, S.A. DE C.V. · Mar 2002
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
K013683 · Abbott Vascular, Inc. · Dec 2001
SUPERSTITCH VASCULAR SUTURING DEVICE
K012865 · Sutura, Inc. · Sep 2001
NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K010909 · Tyco Healthcare Group LP · Apr 2001
GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
K002999 · Gramsmed, LLC · Dec 2000
SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
K002557 · Axya Medical, Inc. · Oct 2000
K010990 · AMS SLING FIXATION SYSTEM
Download PDF FDA Summary American Medical Syst…