Cleared Traditional

K982597 - FIBRCOL PLUS COLLAGEN WOUND DRESSING WI...

K982597 · Johnson & Johnson Medical, Inc. · General & Plastic Surgery device

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Aug 1998

Decision

27d

Days

Risk

K982597 is an FDA 510(k) clearance for the FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Johnson & Johnson Medical, Inc. (Arlington, US). The FDA issued a Cleared decision on August 20, 1998 after a review of 27 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 Johnson & Johnson Medical, Inc. devices

Submission Details

510(k) Number	K982597 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 24, 1998
Decision Date	August 20, 1998
Days to Decision	27 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

88d faster than avg

Panel avg: 115d · This submission: 27d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	KGN Wound Dressing With Animal-derived Material(s)
Device Class	-

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 84

Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K982597.

COLLAGEN TOPICAL WOUND DRESSING

K030921 · Collagen Matrix, Inc. · May 2003

SIGNADRESS DUODERM DRESSING

K990964 · Convatec, A Division of E.R. Squibb & Sons · May 1999

HA ABSORBENT WOUND DRESSING

K984388 · Convatec, A Division of E.R. Squibb & Sons · Mar 1999

KENDALL HYDROPHILIC POWDER WOUND DRESSING

K970266 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1997

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K982597

Johnson & Johnson Medical, Inc.

Arlington, TX · US

TERRY J DAGNON

Regulatory profile

53 submissions 50 cleared

94% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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