Cleared Traditional

UNISILK (K042282) - FDA 510(k) Clearance

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

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.

View all United Medical Industries Co. , Ltd. devices

Submission Details

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
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.

Device Classification

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 40
Devices cleared under the same product code (GAP) and FDA review panel - the closest regulatory comparables to K042282.
Sofsilk™ Coated Braided Silk Suture
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SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture
K222944 · Safepath Medical, Inc. · Oct 2024
Non absorbable Surgical Silk Suture
K232355 · Shandong Haidike Medical Product Co., Ltd. · Jan 2024
Surgical Sutures with or without Needle
K221767 · Huaian Seamen Medical Technology Co., Ltd. · Jul 2023
SafePath Suturing System
K180701 · Safepath Medical, Inc. · Jun 2018