Cleared Special

K010909 - NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE

K010909 is an FDA 510(k) clearance for NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE, manufactured by Tyco Healthcare Group LP. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Special 510(k) pathway after a 14-day FDA review.

K010909 · Tyco Healthcare Group LP · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
14d
Days
Class 2
Risk

K010909 is an FDA 510(k) clearance for the NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Tyco Healthcare Group LP (Norwalk, US). The FDA issued a Cleared decision on April 9, 2001 after a review of 14 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. 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 Tyco Healthcare Group LP devices

FDA 510(k) Submission Details - K010909

510(k) Number K010909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2001
Decision Date April 09, 2001
Days to Decision 14 days
Submission Type Special
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
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 77
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K010909.
MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE
K013683 · Abbott Vascular, Inc. · Dec 2001
SUPERSTITCH VASCULAR SUTURING DEVICE
K012865 · Sutura, Inc. · Sep 2001
AMS SLING FIXATION SYSTEM
K010990 · American Medical Systems, Inc. · Jun 2001
GRAMS POLYPROPYLENE NONABSORBABLE SUTURE
K002999 · Gramsmed, LLC · Dec 2000
SUTURE WELDING SYSTEM AND KIT-(J-TIP DESIGN)
K002557 · Axya Medical, Inc. · Oct 2000
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
K001703 · Abbott Vascular, Inc. · Oct 2000