Cleared Traditional

K143637 - U&U Sterilization Pouch and Roll

K143637 is the FDA 510(k) clearance for U&U Sterilization Pouch and Roll by U&U Medical Technology Co, Ltd.. It is a Class 2 General Hospital device (product code FRG) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K143637 · U&U Medical Technology Co, Ltd. · General Hospital
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Sep 2015
Decision
261d
Days
Class 2
Risk

K143637 is an FDA 510(k) clearance for the U&U Sterilization Pouch and Roll. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by U&U Medical Technology Co, Ltd. (Changzhou,Jiangshu, CN). The FDA issued a Cleared decision on September 9, 2015 after a review of 261 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all U&U Medical Technology Co, Ltd. devices

Submission Details

510(k) Number K143637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2014
Decision Date September 09, 2015
Days to Decision 261 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 129d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 119
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K143637.
Gemini Bonded Sterilization Wrap
K152458 · Medline Industries, Inc. · Jun 2016
Gemini Sterilization Wrap
K150698 · Medline Industries, Inc. · Nov 2015
Wire Sterilization Package with Indicators
K143117 · American Orthodontics · Oct 2015
Gemini Bonded Sterilization Wrap
K143147 · Medline Industries, Inc. · May 2015
Tyvek® Pouch/Roll with STERRAD® Chemical Indicator
K141693 · Advanced Sterilization Products · Dec 2014
KIMGUARD SMART-FOLD STERILIZATION WRAP
K140963 · Kimberly-Clark Corp. · Nov 2014