# K223116: 8X-10-6XXX Camera Head

- Pathway: 510(k) (Traditional)
- Applicant: Santa Barbara Imaging Systems
- Decided: Feb 28, 2023 after 148 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The 8X-10-XXXX Camera System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The 8X-10-XXXX Camera System is indicated for use with a compatible 8X-10-XXXX Camera Head and other accessory devices including an endoscope, optical coupler, and light cable.

Source page: https://510kreport.com/device/K223116
Methodology: https://510kreport.com/methodology