Cleared Traditional

AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber (K173675) - FDA 510(k) Clearance

K173675 · Convatec Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2018
Decision
232d
Days
-
Risk

K173675 is an FDA 510(k) clearance for the AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening .... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec Limited (Deeside, GB). The FDA issued a Cleared decision on July 20, 2018 after a review of 232 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 Convatec Limited devices

Submission Details

510(k) Number K173675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2017
Decision Date July 20, 2018
Days to Decision 232 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 115d · This submission: 232d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
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