# K241990: SpineSite Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Hydrocision, Inc.
- Decided: Jul 30, 2025 after 387 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K950862 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201134: Arthrex NanoScope System, Arthrex, Inc. (2020) Summary page 5.

## Indications for use
The HydroCision SpineSite System is intended to be used as a single-use endoscopic video camera in a variety of endoscopic diagnostic and surgical procedures for spine applications. The device is also intended to be used as an accessory for microscopic surgery.

Source page: https://510kreport.com/device/K241990
Methodology: https://510kreport.com/methodology