Cleared Traditional

DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID (K930588) - FDA 510(k) Clearance

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

K930588 · Davis & Geck, Inc. · General & Plastic Surgery device
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Jan 1994
Decision
337d
Days
Class 2
Risk

K930588 is an FDA 510(k) clearance for the DEXON S, DEXON PLUS, AND DEXON II POLYCOLIC ACID. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Davis & Geck, Inc. (Danbury, US). The FDA issued a Cleared decision on January 7, 1994 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Davis & Geck, Inc. devices

Submission Details

510(k) Number K930588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1993
Decision Date January 07, 1994
Days to Decision 337 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 115d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 63
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K930588.
USSC POLYSORB SUTURE
K951520 · United States Surgical, A Division of Tyco Healthc · Aug 1995
VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT
K946271 · Ethicon, Inc. · Jun 1995
VICRYL RAPIDE SUTURE
K944110 · Ethicon, Inc. · Jan 1995
ETHICON* MONOCRYL (POLIGLECAPRONE 25) SUTURE
K930772 · Ethicon, Inc. · Jan 1994
SUTURES
K930360 · Ethicon, Inc. · Dec 1993
SYNTHETIC ABSORBABLE SURGICAL SUTURE
K930746 · United States Surgical, A Division of Tyco Healthc · Nov 1993