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FDA 510(k)

X-RAY DETECTABLE GAUZE SPONGE

K-Number: K895372 · 1989-11-03

ApplicantKeilei Intl., Inc.
Decision Date1989-11-03
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

X-RAY DETECTABLE 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 1989-11-03 under 510(k) number K895372. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-RAY DETECTABLE GAUZE SPONGE?

X-RAY DETECTABLE GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1989-11-03. The listed applicant is Keilei Intl., Inc.. The 510(k) number is K895372.

When did X-RAY DETECTABLE GAUZE SPONGE receive FDA 510(k) clearance?

X-RAY DETECTABLE GAUZE SPONGE received FDA 510(k) clearance on 1989-11-03, under 510(k) number K895372.

Who is the listed applicant for X-RAY DETECTABLE 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 X-RAY DETECTABLE GAUZE SPONGE?

The FDA product code for X-RAY DETECTABLE GAUZE SPONGE is GDY.

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-STERILEK895086GAUZE SPONGE

Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953059KITTNER DISSECTORMedical Perspectives Corp.

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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