Cleared Traditional

K043330 - POLYPROPILENE SURGICAL SUTURES

K043330 is an FDA 510(k) clearance for POLYPROPILENE SURGICAL SUTURES, manufactured by Demetech Corp.. The device is a Class 2 General & Plastic Surgery device with product code GAW cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K043330 · Demetech Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
165d
Days
Class 2
Risk

K043330 is an FDA 510(k) clearance for the POLYPROPILENE SURGICAL SUTURES. Classified as Suture, Nonabsorbable, Synthetic, Polypropylene (product code GAW), Class II - Special Controls.

Submitted by Demetech Corp. (Appollo Beach, US). The FDA issued a Cleared decision on May 16, 2005 after a review of 165 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Demetech Corp. devices

FDA 510(k) Submission Details - K043330

510(k) Number K043330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2004
Decision Date May 16, 2005
Days to Decision 165 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 115d · This submission: 165d
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 42
Devices cleared under the same product code (GAW) and FDA review panel - the closest regulatory comparables to K043330.
PROLENE POLYPROPYLENE NONABSORBABLE SUTURE
K133356 · Ethicon, Inc. · Dec 2013
OPTIMIZED BARB DESIGN
K052962 · Surgical Specialties Corp · Dec 2005
MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
K050947 · United States Surgical, A Division of Tyco Healthc · Jun 2005
CONTOUR MIDFACE OPPOSING UNI-DIRECTIONAL THREADS
K050548 · Surgical Specialties Corp · Apr 2005
CONTOUR NECKLIFT THREADS
K050247 · Surgical Specialties Corp · Mar 2005
CONTOUR FOREHEAD/BROWLIFT THREAD
K042856 · Surgical Specialties Corp · Dec 2004