Cleared Traditional

K142775 - Neuwater TM (HydrocynTM aqua)

K142775 · Vigilenz Medical Devices · General & Plastic Surgery device
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Feb 2015
Decision
140d
Days
-
Risk

K142775 is an FDA 510(k) clearance for the Neuwater TM (HydrocynTM aqua). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Vigilenz Medical Devices (Bukit Minyak, MY). The FDA issued a Cleared decision on February 13, 2015 after a review of 140 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K142775

510(k) Number K142775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2014
Decision Date February 13, 2015
Days to Decision 140 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
25d slower than avg
Panel avg: 115d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 261
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