Cleared Special

K133764 - CHLORASHIELD IV DRESSING WITH CHG ANTIM...

K133764 · Avery Dennison Belgie Bvba · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2014
Decision
92d
Days
-
Risk

K133764 is an FDA 510(k) clearance for the CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Avery Dennison Belgie Bvba (Turnhout, BE). The FDA issued a Cleared decision on March 13, 2014 after a review of 92 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Avery Dennison Belgie Bvba devices

FDA 510(k) Submission Details - K133764

510(k) Number K133764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2013
Decision Date March 13, 2014
Days to Decision 92 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 115d · This submission: 92d
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

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