Cleared Traditional

K990086 - HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM

K990086 · Integra Lifesciences Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
79d
Days
-
Risk

K990086 is an FDA 510(k) clearance for the HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on March 31, 1999 after a review of 79 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.

FDA 510(k) Submission Details - K990086

510(k) Number K990086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1999
Decision Date March 31, 1999
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

KGN Device Classification - Class 0,

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

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

All 194
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K990086.
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN
K000054 · Adri · Mar 2000
SIS WOUND DRESSING II
K993948 · Cook Biotech, Inc. · Jan 2000
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
FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE
K982597 · Johnson & Johnson Medical, Inc. · Aug 1998
SIS WOUND DRESSING
K973170 · Cook Biotech, Inc. · Apr 1998
K990086 · HELIDERM COLLAGEN WOUND DRESSINGS 0.5 GRAM AND 1.0 GRAM
Download PDF FDA Summary Integra Lifesciences …