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K Number
K962972
Device Name
SURGICADE GAUZE SPONGE
Manufacturer
ACCUNEX CANADA,INC.
Date Cleared
1996-10-11

(72 days)

Product Code
EFQ
Regulation Number
N/A
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
K922055,K942070
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Control bleeding, absorb body fluids, and protect wounds from contamination.

Device Description

Surgicade™ Non-Sterile Gauze Sponges are composed of USP Type VII gauze, ourgical on the each Spire Care Spirity and Compose of Carrype of Suble available in thicknesses of 8 ply (2" x 2", 4" x 4", 4" x 8"), 12 ply (2" x 2", 3" x 3", 4" x 4", 4"

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) summary for a medical device (Surgicade™ Non-Sterile Gauze Sponges) and focuses on administrative details, device description, intended use, and comparison to predicate devices for regulatory clearance. It does not include information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

N/A