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FDA 510(k)

AIMED GAUZE SPONGE

K-Number: K865097 · 1987-01-20

ApplicantKor-Medical Industries, Ltd.
Decision Date1987-01-20
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

AIMED GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Kor-Medical Industries, Ltd.. It received FDA 510(k) clearance on 1987-01-20 under 510(k) number K865097. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIMED GAUZE SPONGE?

AIMED GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1987-01-20. The listed applicant is Kor-Medical Industries, Ltd.. The 510(k) number is K865097.

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

AIMED GAUZE SPONGE received FDA 510(k) clearance on 1987-01-20, under 510(k) number K865097.

Who is the listed applicant for AIMED GAUZE SPONGE?

The FDA 510(k) record lists Kor-Medical Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIMED GAUZE SPONGE?

The FDA product code for AIMED 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 Kor-Medical Industries, Ltd. 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.

K865095ROLL BANDAGE, GAUZE BANDAGE, VARIOUS SIZES

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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