Cleared Traditional

K043539 - DEMETECH STERILE SYNTHETIC ABSORBABLE S...

K043539 is an FDA 510(k) clearance for DEMETECH STERILE SYNTHETIC ABSORBABLE S..., manufactured by Demetech Corp.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K043539 · Demetech Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2005
Decision
105d
Days
Class 2
Risk

K043539 is an FDA 510(k) clearance for the DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Demetech Corp. (Appollo Beach, US). The FDA issued a Cleared decision on April 6, 2005 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4493 - 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 - K043539

510(k) Number K043539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2004
Decision Date April 06, 2005
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAM Device Classification - Class 2, Special Controls

Product Code GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4493
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 - GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

All 87
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K043539.
MODIFIED MONODERM MONOFILAMENT, SYNTHETIC, ABSORBABLE SUTURE
K052437 · Surgical Specialties Corp · Nov 2005
MONOCRYL PLUS ANTIBACTERIAL SUTURE
K050845 · Ethicon, Inc. · Jun 2005
LUPINE LOOP
K050771 · Depuy Mitek, A Johnson & Johnson Company · Apr 2005
POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE
K042141 · Teleflex Medical · Sep 2004
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
K042233 · Depuy Mitek, A Johnson & Johnson Company · Sep 2004
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
K041806 · Depuy Mitek, A Johnson & Johnson Company · Aug 2004