Skip to content

SIRIUS Endoscope System (PR-SI-1230)

by Precision Robotics (Hong Kong) Limited

510(k) K250939

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250939 Date29 Aug 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HET
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SIRIUS Endoscope System is a gynecologic laparoscope and accessories used for medical procedures. It is designed to provide visualization and access during surgical interventions in gynecology.

The device is manufactured by Precision Robotics (Hong Kong) Limited and is supplied as a complete system. It is authorized under FDA 510(k) clearance with product code HET and is intended for use in general and plastic surgery settings.

Other devices from Precision Robotics (Hong Kong) Limited