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FDA 510(k)

HYDROFERA SURGICAL SPEAR

K-Number: K974313 · 1998-03-02

ApplicantHydrofera, LLC
Decision Date1998-03-02
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HYDROFERA SURGICAL SPEAR is the device name listed in this FDA 510(k) record. The listed applicant is Hydrofera, LLC. It received FDA 510(k) clearance on 1998-03-02 under 510(k) number K974313. The device is classified under product code HOZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDROFERA SURGICAL SPEAR?

HYDROFERA SURGICAL SPEAR is a medical device that received FDA 510(k) clearance on 1998-03-02. The listed applicant is Hydrofera, LLC. The 510(k) number is K974313.

When did HYDROFERA SURGICAL SPEAR receive FDA 510(k) clearance?

HYDROFERA SURGICAL SPEAR received FDA 510(k) clearance on 1998-03-02, under 510(k) number K974313.

Who is the listed applicant for HYDROFERA SURGICAL SPEAR?

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 SURGICAL SPEAR?

The FDA product code for HYDROFERA SURGICAL SPEAR is HOZ.

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 DRESSINGK974316HYDROFERA FEMORAL WICK

Related Devices (Code: HOZ)

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.

K132796SUNTOUCH EYE SPEARHuizhou Foryou Medical Devices Co., Ltd.K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.K091240ALPHAMED SURGICAL SPEAR, MODEL 70-5000Alphamed, Inc.K082460CENEFOM PVA SURGICAL SPEARLongtek Scientific Co., Ltd.K012196ULTRACELL ABSORBENT STICKUltracell Medical Technologies, Inc.K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGESMedtronic Xomed, 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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