# K221642: SIRIUS Endoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Robotics (Hong Kong) Limited
- Decided: Dec 12, 2022 after 189 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: 10 generations back to K931154 (1993). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190, Olympus Medical Systems Corp. (2013) Summary page 4.

## Most influential descendants
- K250939: SIRIUS Endoscope System (PR-SI-1230) (2025), 0 descendants of its own

## 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/K221642
Methodology: https://510kreport.com/methodology