Cleared Traditional

K023028 - DEMETECH NYLON NONABSORBABLE SUTURE

K023028 is an FDA 510(k) clearance for DEMETECH NYLON NONABSORBABLE SUTURE, manufactured by Demetech Corp.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K023028 · Demetech Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
280d
Days
Class 2
Risk

K023028 is an FDA 510(k) clearance for the DEMETECH NYLON NONABSORBABLE SUTURE. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by Demetech Corp. (Miami, US). The FDA issued a Cleared decision on June 18, 2003 after a review of 280 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5020 - 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.

FDA 510(k) Submission Details - K023028

510(k) Number K023028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2002
Decision Date June 18, 2003
Days to Decision 280 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
165d slower than avg
Panel avg: 115d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
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 - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 51
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K023028.
ARTELON SURGICAL SUTURE
K032160 · Artimplant AB · Nov 2003
S&T MICROSURGICAL SUTURE
K031531 · S & T AG · Sep 2003
ORLON NONABSORABLE SURGICAL SUTURE USP
K030177 · Sri Orion Pharmaceuticals & Sutures · Jul 2003
NYLON SUTURE
K024090 · Aurolab · Feb 2003
SERRALNYL
K020146 · Serral, S.A. DE C.V. · Apr 2002
GRAMS NYLON NONABSORBABLE SUTURE
K003000 · Gramsmed, LLC · Dec 2000