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FDA 510(k)

GAUZE SPONGE (E.W.A. LTD./VARIOUS)

K-Number: K943339 · 1994-08-23

ApplicantE.W.A., Ltd.
Decision Date1994-08-23
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

GAUZE SPONGE (E.W.A. LTD./VARIOUS) is the device name listed in this FDA 510(k) record. The listed applicant is E.W.A., Ltd.. It received FDA 510(k) clearance on 1994-08-23 under 510(k) number K943339. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE SPONGE (E.W.A. LTD./VARIOUS)?

GAUZE SPONGE (E.W.A. LTD./VARIOUS) is a medical device that received FDA 510(k) clearance on 1994-08-23. The listed applicant is E.W.A., Ltd.. The 510(k) number is K943339.

When did GAUZE SPONGE (E.W.A. LTD./VARIOUS) receive FDA 510(k) clearance?

GAUZE SPONGE (E.W.A. LTD./VARIOUS) received FDA 510(k) clearance on 1994-08-23, under 510(k) number K943339.

Who is the listed applicant for GAUZE SPONGE (E.W.A. LTD./VARIOUS)?

The FDA 510(k) record lists E.W.A., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAUZE SPONGE (E.W.A. LTD./VARIOUS)?

The FDA product code for GAUZE SPONGE (E.W.A. LTD./VARIOUS) 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 E.W.A., 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.

K923378USP TYPE VII GAUZE SPONGES

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

View on FDA Database →

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

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