Cleared Traditional

K042284 - UNIMIDE

K042284 is an FDA 510(k) clearance for UNIMIDE, manufactured by United Medical Industries Co. , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GAR cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K042284 · United Medical Industries Co. , Ltd. · General & Plastic Surgery device
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Dec 2004
Decision
101d
Days
Class 2
Risk

K042284 is an FDA 510(k) clearance for the UNIMIDE. Classified as Suture, Nonabsorbable, Synthetic, Polyamide (product code GAR), Class II - Special Controls.

Submitted by United Medical Industries Co. , Ltd. (Riyadh, Central Province, SA). The FDA issued a Cleared decision on December 3, 2004 after a review of 101 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5020 - 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 - K042284

510(k) Number K042284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2004
Decision Date December 03, 2004
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAR Device Classification - Class 2, Special Controls

Product Code GAR Suture, Nonabsorbable, Synthetic, Polyamide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5020
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 - GAR Suture, Nonabsorbable, Synthetic, Polyamide

All 56
Devices cleared under the same product code (GAR) and FDA review panel - the closest regulatory comparables to K042284.
QUILL NONABSORBABLE NYLON BARBED SUTURE
K052900 · Quill Medical, Inc. · Nov 2005
ARTELON SURGICAL SUTURE
K052482 · Artimplant AB · Oct 2005
TRULON NON-ABSORBABLE POLYAMIDE SURGICAL SUTURE
K041510 · Sutures India Private Limited · Jun 2005
NYLON THREADED NEEDLE
K042367 · Aros Surgical Instruments Corp. · Oct 2004
ARTELON SURGICAL SUTURE
K032160 · Artimplant AB · Nov 2003
S&T MICROSURGICAL SUTURE
K031531 · S & T AG · Sep 2003
K042284 · UNIMIDE
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