Cleared Traditional

K080097 - MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET (FDA 510(k) Clearance)

K080097 · Medtrade Products , Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2008
Decision
177d
Days
-
Risk

K080097 is an FDA 510(k) clearance for the MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET. 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 July 9, 2008 after a review of 177 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 K080097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2008
Decision Date July 09, 2008
Days to Decision 177 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
63d slower than avg
Panel avg: 114d · This submission: 177d
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
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