Cleared Traditional

K042285 - UNICRYL M

K042285 is an FDA 510(k) clearance for UNICRYL M, manufactured by United Medical Industries Co. , Ltd.. The device is a Class 2 General & Plastic Surgery device with product code NEW cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K042285 · United Medical Industries Co. , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
108d
Days
Class 2
Risk

K042285 is an FDA 510(k) clearance for the UNICRYL M. Classified as Suture, Surgical, Absorbable, Polydioxanone (product code NEW), Class II - Special Controls.

Submitted by United Medical Industries Co. , Ltd. (Riyadh, Central Province, SA). The FDA issued a Cleared decision on December 10, 2004 after a review of 108 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4840 - 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

FDA 510(k) Submission Details - K042285

510(k) Number K042285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2004
Decision Date December 10, 2004
Days to Decision 108 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
7d faster than avg
Panel avg: 115d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEW Device Classification - Class 2, Special Controls

Product Code NEW Suture, Surgical, Absorbable, Polydioxanone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4840
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 - NEW Suture, Surgical, Absorbable, Polydioxanone

All 39
Devices cleared under the same product code (NEW) and FDA review panel - the closest regulatory comparables to K042285.
SHARPOINT PDO (POLYDIOXANONE) SUTURES
K063680 · Surgical Specialties Corp · May 2007
PDS PLUS ANTIBACTERIAL SUTURE
K061037 · Ethicon, Inc. · Jul 2006
CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
K053380 · Surgical Specialties Corp · Jan 2006
MONO-SWIFT
K030786 · Cp Medical · May 2003
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE
K013274 · Cp Medical · Nov 2001