Cleared Traditional

K123071 - VASHE SKIN AND WOUND HYDROGEL

K123071 · Puricore, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2013
Decision
115d
Days
-
Risk

K123071 is an FDA 510(k) clearance for the VASHE SKIN AND WOUND HYDROGEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Puricore, Inc. (Malvern, US). The FDA issued a Cleared decision on January 24, 2013 after a review of 115 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.

View all Puricore, Inc. devices

FDA 510(k) Submission Details - K123071

510(k) Number K123071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2012
Decision Date January 24, 2013
Days to Decision 115 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
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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