ENDOCAM Flex HD Camera System 5521

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K161204 ↗

FDA Product Code

FET

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the ENDOCAM Flex HD Camera System 5521 used for?

  The ENDOCAM Flex HD Camera System 5521 is used for diagnostic and therapeutic endoscopic procedures in gastroenterology and urology, providing high-definition video imaging when paired with its controller and camera head.

• Is the ENDOCAM Flex HD Camera System 5521 reusable or single-use?

  The ENDOCAM Flex HD Camera System 5521 is supplied as a reusable system, meaning it is designed for multiple uses after proper cleaning, disinfection, and sterilization in accordance with the manufacturer’s instructions.

• What components are included in the ENDOCAM Flex HD Camera System 5521?

  The system includes a 1-chip HD camera head (model 5521902) and the ENDOCAM Flex HD Controller (model 5521101), which work together to provide endoscopic video imaging for clinical use.

• Who is authorized to operate the ENDOCAM Flex HD Camera System 5521?

  The system is designed for use by specialized medical personnel who have received appropriate training and qualification to operate endoscopic video imaging systems safely and effectively.

• What regulatory pathway was used for the ENDOCAM Flex HD Camera System 5521?

  The ENDOCAM Flex HD Camera System 5521 was cleared through the FDA 510(k) process as a substantially equivalent device, with clearance granted under product code FET and regulation number 876.1500.