Cleared Traditional

K042282 - UNISILK

K042282 is an FDA 510(k) clearance for UNISILK, manufactured by United Medical Industries Co. , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAP cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K042282 · United Medical Industries Co. , Ltd. · General & Plastic Surgery device
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Dec 2004
Decision
99d
Days
Class 2
Risk

K042282 is an FDA 510(k) clearance for the UNISILK. Classified as Suture, Nonabsorbable, Silk (product code GAP), Class II - Special Controls.

Submitted by United Medical Industries Co. , Ltd. (Riyadh, Central Province, SA). The FDA issued a Cleared decision on December 1, 2004 after a review of 99 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K042282

510(k) Number K042282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2004
Decision Date December 01, 2004
Days to Decision 99 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 115d · This submission: 99d
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 39
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K042282.
NON-ABSORBABLE SILK SUTURE
K071111 · Arrow Intl., Inc. · Jul 2007
MANI NEEDLE & SUTURE PACK (SILK)
K053638 · Mani, Inc. · May 2006
TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
K041514 · Sutures India Private Limited · Jun 2005
SILK SUTURES
K024091 · Aurolab · Feb 2003
DEMETECH SILK NONABSORBABLE SUTURE
K023029 · Demetech Corp. · Nov 2002
SERRALSILK
K020901 · Serral, S.A. DE C.V. · Apr 2002
K042282 · UNISILK
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