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FDA 510(k)

SURGICADE GAUZE SPONGE

K-Number: K962972 · 1996-10-11

ApplicantAccunex Canada,Inc.
Decision Date1996-10-11
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

SURGICADE GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Accunex Canada,Inc.. It received FDA 510(k) clearance on 1996-10-11 under 510(k) number K962972. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICADE GAUZE SPONGE?

SURGICADE GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1996-10-11. The listed applicant is Accunex Canada,Inc.. The 510(k) number is K962972.

When did SURGICADE GAUZE SPONGE receive FDA 510(k) clearance?

SURGICADE GAUZE SPONGE received FDA 510(k) clearance on 1996-10-11, under 510(k) number K962972.

Who is the listed applicant for SURGICADE GAUZE SPONGE?

The FDA 510(k) record lists Accunex Canada,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGICADE GAUZE SPONGE?

The FDA product code for SURGICADE GAUZE SPONGE is EFQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EFQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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