Cleared Traditional

K090780 - MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTA...

K090780 · Medtrade Products , Ltd. · General & Plastic Surgery device
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Nov 2009
Decision
242d
Days
-
Risk

K090780 is an FDA 510(k) clearance for the MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Medtrade Products , Ltd. (Cheshire, GB). The FDA issued a Cleared decision on November 20, 2009 after a review of 242 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.

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FDA 510(k) Submission Details - K090780

510(k) Number K090780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2009
Decision Date November 20, 2009
Days to Decision 242 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
127d slower than avg
Panel avg: 115d · This submission: 242d
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 30
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K090780.
StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
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Axiostat Chitosan Hemostatic Dressing
K172324 · Advamedica, Inc. · Feb 2018
CELSTAT
K103245 · Baxter Healthcare Corp · Mar 2011
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004