Cleared Traditional

K011026 - FORTADERM WOUND DRESSING

K011026 · Organogenesis, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
70d
Days
-
Risk

K011026 is an FDA 510(k) clearance for the FORTADERM WOUND DRESSING. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Organogenesis, Inc. (Canton, US). The FDA issued a Cleared decision on June 13, 2001 after a review of 70 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 Organogenesis, Inc. devices

FDA 510(k) Submission Details - K011026

510(k) Number K011026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2001
Decision Date June 13, 2001
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
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 179
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K011026.
SS MATRIX
K020732 · Cook Biotech, Inc. · May 2002
PROMOGRAN MATRIX WOUND DRESSING
K014129 · Johnson & Johnson Medical, Ltd. · Feb 2002
COLLATEK POWDER
K012990 · Biocore Medical Technologies, Inc. · Oct 2001
FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING
K003134 · Adri/Technam · Dec 2000
COLLAGEN WOUND DRESSING
K002443 · Oasis Research, LLC · Oct 2000
MEDTRADE PRODUCTS ALGINATE ISLAND
K000487 · Medtrade Products , Ltd. · Apr 2000