# K261260: HD Camera Head OLYMPUS CH-S200-08-LB

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corporation
- Decided: Jun 24, 2026 after 69 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: 10 generations back to K931154 (1993). 34 ancestors in all.
No later device cites it as a predicate yet.
3 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190449: Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head, Olympus Medical Systems Corp. (2019) Summary page 5.

## Indications for use
The HD Camera Head OLYMPUS CH-S200-08-LB has been designed to be used with endoscopes, video system center, and other ancillary equipment for endoscopic observation, diagnosis and treatment.

Source page: https://510kreport.com/device/K261260
Methodology: https://510kreport.com/methodology