Cleared Traditional

K023028 - DEMETECH NYLON NONABSORBABLE SUTURE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023028 · Demetech Corp. · General & Plastic Surgery device
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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.

View all Demetech Corp. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 114d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 55
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K023028.
Tissue Approximation System (TAS)
K220980 · Tas Medical, Inc. · Jul 2023
Golnit Nylon Monofilament Suture
K212888 · Antarma, LLC Dba Golnit Sutures · Mar 2022
Non Absorbable Surgical Nylon Suture
K212603 · Shandong Haidike Medical Product Co., Ltd. · Dec 2021
Crownjun Nylon Suture
K192420 · Kono Seisakusho Co., Ltd. · May 2020