Cleared Special

K092232 - MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014

K092232 · Puricore, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
27d
Days
-
Risk

K092232 is an FDA 510(k) clearance for the MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Puricore, Inc. (Malvern, US). The FDA issued a Cleared decision on August 19, 2009 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K092232

510(k) Number K092232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2009
Decision Date August 19, 2009
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 638
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