(72 days)
Control bleeding, absorb body fluids, and protect wounds from contamination.
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"
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.
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K962972
Oct. 11, 1996
510 (k) SUMMARY
ADMINISTRATIVE -
Submitter: Accunex Canada, Inc. 202-2117 West 5th Avenue Vancouver, B.C. Canada V6J 1P8 604-736-4219
Contact Person: Mr. Xianping Huang
Date of Preparation: July 30, 1996
DEVICE NAME ll.
Proprietary Name: Surgicade™ Non-Sterile Gauze Sponges Common Name: Wound Dressing Classification Name: Gauze Sponge
PREDICATE DEVICES ==============================================================================================================================================================================
Non-Sterile Gauze Sponges (Team Mfg., Inc.); K922055. Lorrex Cover Sponges, Non-Sterile (Lorrex Health Products); K942070
IV. 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"
v. INTENDED USE
Control bleeding, absorb body fluids, and protect wounds from contamination.
VI. COMPARISON TO PREDICATE DEVICES
Surgicade™ Non-Sterile Gauze Sponges are similar or identical in composition, function and intended use to legally marketed gauze sponges, such as Non-Sterile Gauze Sponges (Team Mfg., Inc.) and Lorrex Cover Sponges, Non-Sterile (Lorrex Health Products). All such devices are composed of absorbent gauze in various thicknesses and sizes, and have the same intended use.
Accordingly, Accunex Canada Inc. has concluded that the Surgicade™ Non-Sterile Gauze Sponges are safe and effective for their intended use and perform at least as well as legally marketed predicate devices, such as the Team Non-Sterile Gauze Sponges and I orrex Non-Sterile Cover Sponges.
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