# K161204: ENDOCAM Flex HD Camera System 5521

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corporation
- Decided: Jan 11, 2017 after 258 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K950862 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080977: 3 CCD Endocam 5550, Richard Wolf Medical Instruments Corp. (2008) Summary page 4.
- K130423: The Richard Wolf Endocam Logic HD Camera System 5525, Richard Wolf Medical Instruments Corp. (2013) Summary page 4.

## Indications for use
The ENDOCAM Flex HD Controller has been designed for video endoscopy and can be used for both diagnostic and therapeutic interventions. The camera controller has an HDMI output suitable for connecting an image output device (monitor). This product is designed exclusively for use by specialized medical personnel and may only be applied by medically qualified and adequately trained persons. The 1-chip HD camera head 5521902 is used for diagnostic and therapeutic operations in conjunction with ENDOCAM Flex HD Controller 5521101. This product is designed exclusively for use by specialized medical personnel and may only be applied by medically qualified and adequately trained persons.

Source page: https://510kreport.com/device/K161204
Methodology: https://510kreport.com/methodology