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FDA 510(k)

DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)

K-Number: K963188 · 1996-10-30

ApplicantCodi International BV
Decision Date1996-10-30
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Codi International BV. It received FDA 510(k) clearance on 1996-10-30 under 510(k) number K963188. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)?

DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) is a medical device that received FDA 510(k) clearance on 1996-10-30. The listed applicant is Codi International BV. The 510(k) number is K963188.

When did DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) receive FDA 510(k) clearance?

DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) received FDA 510(k) clearance on 1996-10-30, under 510(k) number K963188.

Who is the listed applicant for DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)?

The FDA 510(k) record lists Codi International BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)?

The FDA product code for DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) 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 Codi International BV 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.

K961061CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)

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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