Cleared Traditional

DEXON VIOLET (K972566) - FDA 510(k) Clearance

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

K972566 · Davis & Geck, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
36d
Days
Class 2
Risk

K972566 is an FDA 510(k) clearance for the DEXON VIOLET. Classified as Suture, Absorbable, Synthetic, Polyglycolic Acid (product code GAM), Class II - Special Controls.

Submitted by Davis & Geck, Inc. (Hazlewood, US). The FDA issued a Cleared decision on August 14, 1997 after a review of 36 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Davis & Geck, Inc. devices

Submission Details

510(k) Number K972566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1997
Decision Date August 14, 1997
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
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 K972566.
POLYSORB SUTURE
K981935 · United States Surgical, A Division of Tyco Healthc · Jun 1998
SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE
K980704 · Aesculap, Inc. · May 1998
PANACRYL
K974299 · Ethicon, Inc. · Feb 1998
MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS
K971208 · Medline Industries, Inc. · May 1997
MODIFIED USSC* POLYSORB SUTURE
K970863 · United States Surgical, A Division of Tyco Healthc · May 1997
MODIFIED E-PACK PROCEDURE KIT
K970317 · Ethicon, Inc. · Apr 1997