Cleared Traditional

K090026 - CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266

K090026 · Hem Con Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
85d
Days
-
Risk

K090026 is an FDA 510(k) clearance for the CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hem Con Medical Technologies, Inc. (Portland, US). The FDA issued a Cleared decision on March 31, 2009 after a review of 85 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 - K090026

510(k) Number K090026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2009
Decision Date March 31, 2009
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

QSY Device Classification - Class 0,

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 124
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K090026.
CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2
K092357 · Hem Con Medical Technologies, Inc. · Aug 2009
ALGISEAL PAD
K091194 · Evolution Medical Technologies, LLC · May 2009
QUIKCLOT INTEVENTIONAL, MODEL P/N 182
K090620 · Z-Medica Corporation · Apr 2009
SOFTSEAL-STF
K090100 · Chitogen, Inc. · Mar 2009
PRO QR ADVANCED FORMULA POWDER
K080210 · Biolife, LLC · Feb 2009
BENACEL, MODELS C-001, C-002 AND C-005
K080532 · Unicare Biomedical, Inc. · Nov 2008