Cleared Traditional

K980610 - DEXON RAPID (DEXON R)

K980610 is an FDA 510(k) clearance for DEXON RAPID (DEXON R), manufactured by Davis & Geck, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980610 · Davis & Geck, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
90d
Days
Class 2
Risk

K980610 is an FDA 510(k) clearance for the DEXON RAPID (DEXON R). 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 May 18, 1998 after a review of 90 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 Davis & Geck, Inc. devices

FDA 510(k) Submission Details - K980610

510(k) Number K980610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date May 18, 1998
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 94
Devices cleared under the same product code (GAM) and FDA review panel - the closest regulatory comparables to K980610.
SURGISORB
K990432 · Sutures , Ltd. · May 1999
MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE
K990951 · United States Surgical, A Division of Tyco Healthc · Apr 1999
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
DEXON VIOLET
K972566 · Davis & Geck, Inc. · Aug 1997