# K250939: SIRIUS Endoscope System (PR-SI-1230)

- Pathway: 510(k) (Traditional)
- Applicant: Precision Robotics (Hong Kong) Limited
- Decided: Aug 29, 2025 after 154 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931154 (1993). 38 ancestors in all.
No later device cites it as a predicate yet.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221642: SIRIUS Endoscope System, Precision Robotics (Hong Kong) Limited (2022) Summary page 5.

## Indications for use
It is intended for use for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including female reproductive organs. Not suitable for use for observation and treatment of the heart and must not contact the heart or its vicinity.

Source page: https://510kreport.com/device/K250939
Methodology: https://510kreport.com/methodology