Cleared Traditional

K061467 - EXSEPT WC WOUND CLEANSER

K061467 · Alcavis International, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
265d
Days
-
Risk

K061467 is an FDA 510(k) clearance for the EXSEPT WC WOUND CLEANSER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Alcavis International, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on February 15, 2007 after a review of 265 days - an extended review 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: 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 Alcavis International, Inc. devices

FDA 510(k) Submission Details - K061467

510(k) Number K061467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2006
Decision Date February 15, 2007
Days to Decision 265 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
150d slower than avg
Panel avg: 115d · This submission: 265d
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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