Cleared Special

AQUACEL Ag Surgical SP Dressing (K152926) - FDA 510(k) Clearance

K152926 · Convatec Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
108d
Days
-
Risk

K152926 is an FDA 510(k) clearance for the AQUACEL Ag Surgical SP Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec Limited (Deeside, GB). The FDA issued a Cleared decision on January 21, 2016 after a review of 108 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 Convatec Limited devices

Submission Details

510(k) Number K152926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2015
Decision Date January 21, 2016
Days to Decision 108 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
7d faster than avg
Panel avg: 115d · This submission: 108d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K152926.
Catasyn Advanced Technology Wound Hydrogel
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Prontosan Wound Gel
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K161623 · B.Braun Medical, Inc. · Nov 2016
PRONTOSAN WOUND GEL X
K130857 · B.Braun Medical, Inc. · Oct 2013
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
K123679 · 3M Company · Feb 2013
CURAD ANTIBACTERIAL BANDAGE
K113583 · Medline Industries, Inc. · Apr 2012