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FDA 510(k)

GAUZE SPONGE

K-Number: K895086 · 1989-10-23

ApplicantKeilei Intl., Inc.
Decision Date1989-10-23
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Keilei Intl., Inc.. It received FDA 510(k) clearance on 1989-10-23 under 510(k) number K895086. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE SPONGE?

GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1989-10-23. The listed applicant is Keilei Intl., Inc.. The 510(k) number is K895086.

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

GAUZE SPONGE received FDA 510(k) clearance on 1989-10-23, under 510(k) number K895086.

Who is the listed applicant for GAUZE SPONGE?

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

What is the FDA product code for GAUZE SPONGE?

The FDA product code for 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Keilei Intl., Inc. as applicant

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.

K913779BANDAGE ROLL, GAUZEK912779GAUZE SPONGE,STERILE 2'SK913575GAUZE PACKING, SURGICAL STERILE AND NON-STERILEK895372X-RAY DETECTABLE GAUZE SPONGE

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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