Cleared Traditional

PERCLOT TOPICAL

K132105 · Cryolife, Inc. · General & Plastic Surgery
Apr 2014
Decision
269d
Days
—
Risk

About This 510(k) Submission

K132105 is an FDA 510(k) clearance for the PERCLOT TOPICAL, a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Cryolife, Inc. (Kennesaw, US). The FDA issued a Cleared decision on April 3, 2014, 269 days after receiving the submission on July 8, 2013. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K132105 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2013
Decision Date April 03, 2014
Days to Decision 269 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code QSY — Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class —
Definition To Temporarily Control Bleeding And Cover External Wounds.

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