Cleared Traditional

K132105 - PERCLOT TOPICAL

K132105 · Cryolife, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
269d
Days
-
Risk

K132105 is an FDA 510(k) clearance for the PERCLOT TOPICAL. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Cryolife, Inc. (Kennesaw, US). The FDA issued a Cleared decision on April 3, 2014 after a review of 269 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 Cryolife, Inc. devices

FDA 510(k) Submission Details - K132105

510(k) Number K132105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 115d · This submission: 269d
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 77
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K132105.
D2 HEMOSTANTIC DRESSING
K140757 · Z-Medica, LLC · Jul 2014
BONDILOXS TOPICAL HEMOSTATIC DRESSING
K132333 · Medtrade Products , Ltd. · Jun 2014
CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
K133121 · Sam Medical Products · May 2014
STATSEAL DISC
K130324 · Biolife, LLC · Jul 2013
QUIKCLOT HEMOSTATIC DRESSING
K123387 · Z-Medica, LLC · Apr 2013
INTERVENTIONAL HEMOSTATIC BANDAGE
K120782 · Z-Medica Corporation · Mar 2013