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FDA 510(k)

Processor VP-7000, Light Source BL-7000

K-Number: K163675 · 2017-04-25

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2017-04-25
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Processor VP-7000, Light Source BL-7000 is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K163675. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Processor VP-7000, Light Source BL-7000?

Processor VP-7000, Light Source BL-7000 is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K163675.

When did Processor VP-7000, Light Source BL-7000 receive FDA 510(k) clearance?

Processor VP-7000, Light Source BL-7000 received FDA 510(k) clearance on 2017-04-25, under 510(k) number K163675.

Who is the listed applicant for Processor VP-7000, Light Source BL-7000?

The FDA 510(k) record lists Fujifilm Medical System U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Processor VP-7000, Light Source BL-7000?

The FDA product code for Processor VP-7000, Light Source BL-7000 is FET.

Other records listing Fujifilm Medical System U.S.A., 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.

K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)

Related Devices (Code: FET)

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.

K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation

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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