Cleared Traditional

K032986 - CLO-SURPLUSP.A.D.

K032986 · Scion Cardio-Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
159d
Days
-
Risk

K032986 is an FDA 510(k) clearance for the CLO-SURPLUSP.A.D.. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Scion Cardio-Vascular, Inc. (Miami, US). The FDA issued a Cleared decision on March 1, 2004 after a review of 159 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 - K032986

510(k) Number K032986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2003
Decision Date March 01, 2004
Days to Decision 159 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
44d slower than avg
Panel avg: 115d · This submission: 159d
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 126
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K032986.
QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172
K050769 · Z-Medica Corporation · Apr 2005
NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
K040208 · Tz Medical, Inc. · May 2004
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004
HEMADERM
K033666 · Medafor, Inc. · Dec 2003
HEMCON BANDAGE OTC
K030946 · Hemcon, Inc. · Jun 2003
T-SCIENTIFIC T-PAD
K030334 · T-Scientific, Inc. · Apr 2003
K032986 · CLO-SURPLUSP.A.D.
Download PDF FDA Summary Scion Cardio-Vascular…