Cleared Traditional

K052536 - ALGICELL AG

K052536 · Derma Sciences Canada, Inc. · General & Plastic Surgery device
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Sep 2006
Decision
363d
Days
-
Risk

K052536 is an FDA 510(k) clearance for the ALGICELL AG. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Derma Sciences Canada, Inc. (Toronto, Orntario, CA). The FDA issued a Cleared decision on September 13, 2006 after a review of 363 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 Derma Sciences Canada, Inc. devices

FDA 510(k) Submission Details - K052536

510(k) Number K052536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2005
Decision Date September 13, 2006
Days to Decision 363 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 115d · This submission: 363d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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