Cleared Special

MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE (K050947) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K050947 · United States Surgical, A Division of Tyco Healthc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
47d
Days
Class 2
Risk

K050947 is an FDA 510(k) clearance for the MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on June 1, 2005 after a review of 47 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K050947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2005
Decision Date June 01, 2005
Days to Decision 47 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
68d faster than avg
Panel avg: 115d · This submission: 47d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 19
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K050947.
Gazelle Polypropylene Suture and Delivery Device
K173644 · Dura Tap, LLC · Feb 2018
AESCULAP OPTILENE NONABSORBABLE SUTURE
K133890 · Aesculap, Inc. · Jul 2014
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · Ethicon, Inc. · Dec 2013
PRONOVA NONABSORBABLE SUTURE, USP
K001625 · Ethicon, Inc. · Jul 2000
PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE
K980703 · Aesculap, Inc. · May 1998
VIEWPOINT
K961168 · Philips Medical Systems (Cleveland), Inc. · May 1996