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FDA 510(k)

I.V.IRRIGATION POLE

K-Number: K915065 · 1992-02-11

ApplicantAmerican Medical Mfg., Inc.
Decision Date1992-02-11
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

I.V.IRRIGATION POLE is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Mfg., Inc.. It received FDA 510(k) clearance on 1992-02-11 under 510(k) number K915065. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.V.IRRIGATION POLE?

I.V.IRRIGATION POLE is a medical device that received FDA 510(k) clearance on 1992-02-11. The listed applicant is American Medical Mfg., Inc.. The 510(k) number is K915065.

When did I.V.IRRIGATION POLE receive FDA 510(k) clearance?

I.V.IRRIGATION POLE received FDA 510(k) clearance on 1992-02-11, under 510(k) number K915065.

Who is the listed applicant for I.V.IRRIGATION POLE?

The FDA 510(k) record lists American Medical Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.V.IRRIGATION POLE?

The FDA product code for I.V.IRRIGATION POLE is FOZ.

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 American Medical Mfg., 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.

K982029SHARPS COLLECTION CONTAINER - SAF-T-SHELLK961454AMMI MAGNI-GUARDK915066DISPOSABLE SKIN MARKERK915064DISPOSABLE CAUTERY ABRASIVE PADK915068PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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