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FDA 510(k)

HYDROFERA FEMORAL WICK

K-Number: K974316 · 1998-02-13

ApplicantHydrofera, LLC
Decision Date1998-02-13
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

HYDROFERA FEMORAL WICK is the device name listed in this FDA 510(k) record. The listed applicant is Hydrofera, LLC. It received FDA 510(k) clearance on 1998-02-13 under 510(k) number K974316. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROFERA FEMORAL WICK?

HYDROFERA FEMORAL WICK is a medical device that received FDA 510(k) clearance on 1998-02-13. The listed applicant is Hydrofera, LLC. The 510(k) number is K974316.

When did HYDROFERA FEMORAL WICK receive FDA 510(k) clearance?

HYDROFERA FEMORAL WICK received FDA 510(k) clearance on 1998-02-13, under 510(k) number K974316.

Who is the listed applicant for HYDROFERA FEMORAL WICK?

The FDA 510(k) record lists Hydrofera, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDROFERA FEMORAL WICK?

The FDA product code for HYDROFERA FEMORAL WICK 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 Hydrofera, LLC 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.

K190268Hydrofera Blue READY - BorderK023138HYDROFERA BACTERIOSTATIC WOUND DRESSINGK013462HYDROFERA BACTERIOSTATIC WOUND DRESSINGK983276HYDROFERA BACTERISTATIC NASAL DRESSINGK974313HYDROFERA SURGICAL SPEAR

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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