Cleared Traditional

K003134 - FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING

K003134 · Adri/Technam · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
77d
Days
-
Risk

K003134 is an FDA 510(k) clearance for the FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Adri/Technam (Park Forest, US). The FDA issued a Cleared decision on December 22, 2000 after a review of 77 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 Adri/Technam devices

FDA 510(k) Submission Details - K003134

510(k) Number K003134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2000
Decision Date December 22, 2000
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
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 151
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K003134.
AVAGEN WOUND DRESSING
K022127 · Integra Lifesciences Corp. · Sep 2002
BILAYER MATRIX WOUND DRESSING
K021792 · Integra Lifesciences Corp. · Aug 2002
SS MATRIX
K020732 · Cook Biotech, Inc. · May 2002
MEDTRADE PRODUCTS ALGINATE ISLAND
K000487 · Medtrade Products , Ltd. · Apr 2000
HYCURE ORAL / HYCURE ORAL SMART GEL
K994339 · The Hymed Group Corp. · Mar 2000
SIS WOUND DRESSING II
K993948 · Cook Biotech, Inc. · Jan 2000