Cleared Traditional

SUILE OINTMENT WOUND DRESSING (K041013) - FDA 510(k) Clearance

K041013 · Hedonist Biochemical Technologies Co., Ltd. · General & Plastic Surgery device
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Jul 2004
Decision
78d
Days
-
Risk

K041013 is an FDA 510(k) clearance for the SUILE OINTMENT WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hedonist Biochemical Technologies Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on July 7, 2004 after a review of 78 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 Hedonist Biochemical Technologies Co., Ltd. devices

Submission Details

510(k) Number K041013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2004
Decision Date July 07, 2004
Days to Decision 78 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 115d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 163
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K041013.
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc. · Jun 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030 · Smith & Nephew, Inc. · Apr 2005
3M TEGADERM SILVER
K040890 · 3M Company · Nov 2004
TEGASORB(TM) ULCER DRESSING, #90-XXX
K891288 · 3M Company · Jun 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · Baxter Healthcare Corp · Mar 1989
PHARMASEAL STERILE WOUND CARE DRESSING
K884397 · Baxter Healthcare Corp · Dec 1988