Cleared Traditional

K013936 - SILVERLEAF CONTACT WOUND DRESSING

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.

FDA 510(k) Submission Details - K013936

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
360d slower than avg
Panel avg: 115d · This submission: 475d
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 708
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K013936.
FERRIS POLYMEM SILVER WOUND DRESSING
K031307 · Ferris Mfg. Corp. · Oct 2003
SUILE WOUND DRESSING
K022967 · Hedonist Biochemical Technologies Co., Ltd. · Jul 2003
ANTIMICROBIAL ALGINATE DRESSING
K024298 · Advanced Medical Solutions, Ltd. · Jun 2003
SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES
K020318 · Scivolutions, Inc. · Feb 2003
CONTREET FOAM ADHESIVE/NON-ADHESIVE
K022416 · Coloplast Corp. · Feb 2003
ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING
K022483 · Johnson & Johnson Medical, Ltd. · Feb 2003
K013936 · SILVERLEAF CONTACT WOUND DRESSING
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