Cleared Traditional

K011941 - EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088

K011941 · The Kendall Company · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
62d
Days
-
Risk

K011941 is an FDA 510(k) clearance for the EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by The Kendall Company (Mansfield, US). The FDA issued a Cleared decision on August 22, 2001 after a review of 62 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.

View all The Kendall Company devices

FDA 510(k) Submission Details - K011941

510(k) Number K011941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2001
Decision Date August 22, 2001
Days to Decision 62 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 115d · This submission: 62d
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 586
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K011941.
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · Coloplast Corp. · Feb 2003
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
K012816 · Dynarex Corp. · Oct 2002
ABSORBENT ANTIMICROBIAL WOUND DRESSING
K013814 · Convatec, A Division of E.R. Squibb & Sons · Jun 2002
ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
K992221 · Westaim Biomedical, Inc. · Jun 2000
ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045
K991818 · Acrymed, Inc. · Apr 2000
ACTICOAT FOAM DRESSING
K000051 · Westaim Biomedical, Inc. · Apr 2000