Cleared Traditional

SILVERLEAF CONTACT WOUND DRESSING (K013936) - FDA 510(k) Clearance

K013936 · Silverleaf Technologies, Inc. · General & Plastic Surgery device
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Mar 2003
Decision
475d
Days
-
Risk

K013936 is an FDA 510(k) clearance for the SILVERLEAF CONTACT WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Silverleaf Technologies, Inc. (Ottawa, Ontario, CA). The FDA issued a Cleared decision on March 18, 2003 after a review of 475 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Silverleaf Technologies, Inc. devices

Submission Details

510(k) Number K013936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2001
Decision Date March 18, 2003
Days to Decision 475 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
360d slower than avg
Panel avg: 115d · This submission: 475d
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 K013936.
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