Cleared Traditional

K143466 - Hemogrip Patch

K143466 · Remedium Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 124
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K143466.
HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
K150916 · Hem Con Medical Technologies, Inc. · Nov 2015
AnsCare ChitoClot Pad
K150963 · Benq Materials Corporation · Nov 2015
HEMO-Bandage
K151204 · Coreleader Biotech Co., Ltd. · Jul 2015
AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)
K143462 · Benq Materials Corporation · May 2015
NUSTAT, NUSTAT XR
K142363 · Beeken Biomedical · Jan 2015
WOUNDCLOT HEMOSTATIC GAUZE
K140573 · Core Scientific , Ltd. · Nov 2014