Cleared Traditional

K060901 - VASHE WOUND CLEANSING SYSTEM

K060901 · Sterilox Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
87d
Days
-
Risk

K060901 is an FDA 510(k) clearance for the VASHE WOUND CLEANSING SYSTEM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sterilox Technologies, Inc. (Radnor, US). The FDA issued a Cleared decision on June 29, 2006 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K060901

510(k) Number K060901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2006
Decision Date June 29, 2006
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 115d · This submission: 87d
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 702
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K060804 · Covalon Technologies, Ltd. · Apr 2006
K060901 · VASHE WOUND CLEANSING SYSTEM
Download PDF FDA Summary Sterilox Technologies…