Cleared Traditional

K060901 - VASHE WOUND CLEANSING SYSTEM

K060901 · Sterilox Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Sterilox Technologies, Inc. devices

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
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 325
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K060901.
3M TEGADERM CHG DRESSING
K063458 · 3M Company · Apr 2007
SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
K984204 · Argentum International, LLC · Mar 2007
SILVERLON ADHESIVE STRIP
K984205 · Argentum International, LLC · Mar 2007
BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
K050086 · Brennen Medical, Inc. · Feb 2006
3M TEGADERM SILVER (AG) MESH
K053256 · 3M Company · Dec 2005
MEDLINE IODOFORM PACKING STRIPS
K052720 · Medline Industries, Inc. · Oct 2005