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FDA 510(k)

DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)

K-Number: K963134 · 1996-09-06

ApplicantIgenics, Inc.
Decision Date1996-09-06
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 Igenics, Inc.. It received FDA 510(k) clearance on 1996-09-06 under 510(k) number K963134. 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 1996-09-06. The listed applicant is Igenics, Inc.. The 510(k) number is K963134.

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 1996-09-06, under 510(k) number K963134.

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

The FDA 510(k) record lists Igenics, Inc. 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 Igenics, 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.

K955527GENERAL USE SYNTHETIC SPONGE (STERILE)K955165SYNTHETIC 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

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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