Cleared Traditional

K161274 - Bondiloxs Topical Hemostatic Granules

K161274 · Medtrade Products , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
257d
Days
-
Risk

K161274 is an FDA 510(k) clearance for the Bondiloxs Topical Hemostatic Granules. 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 January 18, 2017 after a review of 257 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 - K161274

510(k) Number K161274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2016
Decision Date January 18, 2017
Days to Decision 257 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
142d slower than avg
Panel avg: 115d · This submission: 257d
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 K161274.
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Axiostat Chitosan Hemostatic Dressing
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CELSTAT
K103245 · Baxter Healthcare Corp · Mar 2011
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004