Cleared Traditional

K143466 - Hemogrip Patch

K143466 · Remedium Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
186d
Days
-
Risk

K143466 is an FDA 510(k) clearance for the Hemogrip Patch. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Remedium Technologies, Inc. (College Park, US). The FDA issued a Cleared decision on June 8, 2015 after a review of 186 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 Remedium Technologies, Inc. devices

FDA 510(k) Submission Details - K143466

510(k) Number K143466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2014
Decision Date June 08, 2015
Days to Decision 186 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
71d slower than avg
Panel avg: 115d · This submission: 186d
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 47
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K143466.
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BONDILOXS TOPICAL HEMOSTATIC DRESSING
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CELOX GAUZE PRO
K113560 · Medtrade Products , Ltd. · Aug 2012
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
K112800 · Huizhou Foryou Medical Devices Co., Ltd. · May 2012