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FDA 510(k)

ENVIEW (TM)

K-Number: K102179 · 2010-12-02

ApplicantCarefusion 2200
Decision Date2010-12-02
Product CodeOCV
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENVIEW (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200. It received FDA 510(k) clearance on 2010-12-02 under 510(k) number K102179. The device is classified under product code OCV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENVIEW (TM)?

ENVIEW (TM) is a medical device that received FDA 510(k) clearance on 2010-12-02. The listed applicant is Carefusion 2200. The 510(k) number is K102179.

When did ENVIEW (TM) receive FDA 510(k) clearance?

ENVIEW (TM) received FDA 510(k) clearance on 2010-12-02, under 510(k) number K102179.

Who is the listed applicant for ENVIEW (TM)?

The FDA 510(k) record lists Carefusion 2200 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENVIEW (TM)?

The FDA product code for ENVIEW (TM) is OCV.

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 Carefusion 2200 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.

K093616V. MUELLER CAMERA CONTROLLER WITH STORAGE CART

Related Devices (Code: OCV)

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.

K240506KARL STORZ HoldersKarl Storz Endoscopy America, Inc.K232405ENDOFIX EXOAktormed GmbHK190576WalterLorenz Surgical Assist Arm Scope HolderBiomet MicrofixationK093616V. MUELLER CAMERA CONTROLLER WITH STORAGE CARTCarefusion 2200K992006NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33Integra Neurocare, LLCK990334KSEA ENDOSCOPE HOLDERKARL STORZ Endoscopy-America, 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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