Cleared Traditional

K083133 - SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS

K083133 · Andover Healthcare, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
372d
Days
-
Risk

K083133 is an FDA 510(k) clearance for the SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX A.... Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Andover Healthcare, Inc. (Salisbury, US). The FDA issued a Cleared decision on October 30, 2009 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Andover Healthcare, Inc. devices

FDA 510(k) Submission Details - K083133

510(k) Number K083133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2008
Decision Date October 30, 2009
Days to Decision 372 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
257d slower than avg
Panel avg: 115d · This submission: 372d
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 609
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K083133.
SILVERSTREAM AND DERMASEPT
K093227 · Enzysurge , Ltd. · Dec 2009
HYLATOPIC PLUS EMOLLIENT FOAM
K093051 · Collegium Pharmaceutical Incorporated · Dec 2009
ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL
K092826 · American Biotech Labs · Nov 2009
ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING
K091354 · Acrymed, Inc. · Oct 2009
ELETONE CREAM
K092297 · Ferndale Pharma Group, Inc. · Oct 2009
SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)
K090254 · Convatec, A Division of E.R. Squibb & Sons, LLC · Sep 2009