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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 a medical device manufactured by Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2017-01-11 under approval 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. It is manufactured by Richard Wolf Medical Instruments Corporation. The 510(k) number is K161204.

When was ENDOCAM Flex HD Camera System 5521 approved by the FDA?

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

What company makes ENDOCAM Flex HD Camera System 5521?

ENDOCAM Flex HD Camera System 5521 is manufactured by Richard Wolf Medical Instruments Corporation.

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.

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Other Devices by Richard Wolf Medical Instruments Corporation

K170377TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM K180583LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD K183188Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF K200617Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 K211332D Camera Controller K203226TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM

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Related Devices (Code: FET)

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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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