Cleared Traditional

K022967 - SUILE WOUND DRESSING

K022967 · Hedonist Biochemical Technologies Co., Ltd. · General & Plastic Surgery device
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Jul 2003
Decision
305d
Days
-
Risk

K022967 is an FDA 510(k) clearance for the SUILE WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hedonist Biochemical Technologies Co., Ltd. (Plano, US). The FDA issued a Cleared decision on July 8, 2003 after a review of 305 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.

FDA 510(k) Submission Details - K022967

510(k) Number K022967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2002
Decision Date July 08, 2003
Days to Decision 305 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
190d slower than avg
Panel avg: 115d · This submission: 305d
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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K022967 · SUILE WOUND DRESSING
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