Cleared Traditional

K091795 - MEDTRADE PRODUCTS CELOX TRAUMA GAUZE (FDA 510(k) Clearance)

K091795 · Medtrade Products , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
156d
Days
-
Risk

K091795 is an FDA 510(k) clearance for the MEDTRADE PRODUCTS CELOX TRAUMA GAUZE. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Medtrade Products , Ltd. (Crewe, GB). The FDA issued a Cleared decision on November 20, 2009 after a review of 156 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtrade Products , Ltd. devices

Submission Details

510(k) Number K091795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2009
Decision Date November 20, 2009
Days to Decision 156 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 114d · This submission: 156d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 126
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K091795.
BloodSTOP iX Trauma Matrix (TM-iX-20)
K253017 · Lifescience Plus, Inc. · Apr 2026
Ganymede 2cm diameter (FG100300)
K251700 · Speciality Fibres and Materials Limited · Feb 2026
MFUSE (MS001)
K250319 · Machina Medical, Inc. · Dec 2025
TRAUMAGEL® 2.0 Hemostatic Gel
K253609 · Cresilon, Inc. · Dec 2025
TRAUMAGEL®
K240713 · Cresilon, Inc. · Aug 2024
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
K240097 · Ushare Medical, Inc. · May 2024