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FDA 510(k)

ENDOCAM Flex HD Camera System 5521

K-Number: K161204 · 2017-01-11

ApplicantRichard Wolf Medical Instruments Corporation
Decision Date2017-01-11
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOCAM Flex HD Camera System 5521 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K161204. 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 ENDOCAM Flex HD Camera System 5521?

ENDOCAM Flex HD Camera System 5521 is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K161204.

When did ENDOCAM Flex HD Camera System 5521 receive FDA 510(k) clearance?

ENDOCAM Flex HD Camera System 5521 received FDA 510(k) clearance on 2017-01-11, under 510(k) number K161204.

Who is the listed applicant for ENDOCAM Flex HD Camera System 5521?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOCAM Flex HD Camera System 5521?

The FDA product code for ENDOCAM Flex HD Camera System 5521 is FET.

Other records listing Richard Wolf Medical Instruments Corporation as applicant

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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

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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