Cleared Traditional

K011941 - EXCILON AMD ANTIMICROBIAL SPONGE MODEL ...

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 227
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K982493 · Coloplast Corp. · Jan 1999
BIATAIN FOAM DRESSING
K983163 · Coloplast Corp. · Dec 1998
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K983173 · Coloplast Corp. · Dec 1998