SIRIUS Endoscope System— 510(k) K221642

Name: FDA 510(k) clearance K221642
Creator: U.S. Food and Drug Administration
Published: 2022-12-12

Substantially Equivalent

Precision Robotics (Hong Kong) Limited

FDA 510(k) clearance K221642 for SIRIUS Endoscope System, Substantially Equivalent on 2022-12-12. Applicant: Precision Robotics (Hong Kong) Limited. Device class: 2.

Clearance details

Applicant: Precision Robotics (Hong Kong) Limited
Product code: Code HET
Device class: Class 2
Regulation: 21 CFR 884.1720
Advisory panel: Obstetrics/Gynecology
Date received: 2022-06-06
Decision date: 2022-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code HET

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K250939 — SIRIUS Endoscope System (PR-SI-1230)2025-08-29
K243821 — i-Cut2025-04-25
K210116 — Video Endoscopy System, 3D Video Endoscopy System2021-10-13
K201832 — Endoeye Flex Deflectable Videoscope Olympus LTF-S190-52021-09-17
K210104 — SurroundScope System2021-07-08

Adverse events under product code HET

product code HET

Malfunction: 10,504
Total: 10,504

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.