Cleared Traditional

K121275 - AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER

K121275 · Convatec, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
89d
Days
-
Risk

K121275 is an FDA 510(k) clearance for the AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, Inc. (Skillman, US). The FDA issued a Cleared decision on July 25, 2012 after a review of 89 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.

FDA 510(k) Submission Details - K121275

510(k) Number K121275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2012
Decision Date July 25, 2012
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
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 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K121275.
SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
K121819 · Covalontechnologies, Inc. · Aug 2012
NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER
K113820 · Novabay Pharmaceuticals · Aug 2012
TL TRISEB CREAM
K121134 · Trigen Laboratories, Inc. · Jul 2012
OXYBAND WOUND DRESSING
K121407 · O2s, LLC · Jul 2012
POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)
K121522 · Polyremedy, Inc. · Jun 2012
CELVER
K111382 · Cellulose Concepts, LLC · May 2012
K121275 · AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
Download PDF FDA Summary Convatec, Inc.