Cleared Traditional

K982853 - SILK SUTURE

K982853 is an FDA 510(k) clearance for SILK SUTURE, manufactured by Davis & Geck, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K982853 · Davis & Geck, Inc. · General & Plastic Surgery device
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Apr 1999
Decision
260d
Days
Class 2
Risk

K982853 is an FDA 510(k) clearance for the SILK SUTURE. Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by Davis & Geck, Inc. (Hazlewood, US). The FDA issued a Cleared decision on April 30, 1999 after a review of 260 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5030 - 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 - K982853

510(k) Number K982853 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 13, 1998
Decision Date April 30, 1999
Days to Decision 260 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 115d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAP Device Classification - Class 2, Special Controls

Product Code GAP Suture, Nonabsorbable, Silk
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5030
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 - GAP Suture, Nonabsorbable, Silk

All 18
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K982853.
SILK Surgical Suture
K162396 · Teleflexmedical, Inc. · Nov 2016
NON-ABSORBABLE SILK SUTURE
K071111 · Arrow Intl., Inc. · Jul 2007
SILK, NONABSORBABLE, SURGICAL SUTURES, USP
K001184 · Cp Medical · Jun 2000
SILKAM NONABSORBABLE SILK SURGICAL SUTURE
K990089 · Aesculap, Inc. · Mar 1999
SOFSILK SUTURE
K981128 · United States Surgical, A Division of Tyco Healthc · May 1998
SOFSILK SUTURE
K980124 · United States Surgical, A Division of Tyco Healthc · Mar 1998