Cleared Traditional

K143444 - SynePure Wound Cleanser

K143444 · Synedgen, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
262d
Days
-
Risk

K143444 is an FDA 510(k) clearance for the SynePure Wound Cleanser. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Synedgen, Inc. (Claremont, US). The FDA issued a Cleared decision on August 21, 2015 after a review of 262 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Synedgen, Inc. devices

Submission Details

510(k) Number K143444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2014
Decision Date August 21, 2015
Days to Decision 262 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 115d · This submission: 262d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 212
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K143444.
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PRONTOSAN WOUND GEL X
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