SIRIUS Endoscope System
FDA 510(k) K221642 · Precision Robotics (Hong Kong) Limited
510(k) numberK221642
Submission
- Device name
- SIRIUS Endoscope System
- Applicant
- Precision Robotics (Hong Kong) Limited
Hong Kong, CN - Received
- June 6, 2022
- Decision date
- December 12, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HET – Laparoscope, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1720
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HET
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230)HET · Traditional | Precision Robotics (Hong Kong) Limited | 08/29/2025SE |
| K243821 | i-CutHET · Traditional | A.M.I. Agency For Medical Innovations GmbH | 04/25/2025SE |
| K210116 | Video Endoscopy System, 3D Video Endoscopy SystemHET · Traditional | Surgnova Healthcare Technologies (Zhejiang) Co.… | 10/13/2021SE |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5HET · Traditional | Olympus Medical Systems Corp. | 09/17/2021SE |
| K210104 | SurroundScope SystemHET · Traditional | 270surgical , Ltd. | 07/08/2021SE |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…HET · Traditional | Schoelly Fiberoptic GmbH | 03/12/2021SE |
| K200216 | 4K UHD Camera SystemHET · Traditional | Scivita Medical Technology Co., Ltd. | 08/21/2020SE |
| K200638 | LAP-iX Suction IrrigationHET · Special | Sejong Medical Co., Ltd. | 04/03/2020SE |
| K190190 | WV1 EndoscopeHET · Traditional | 270surgical , Ltd. | 11/01/2019SE |
| K190744 | Endoeye HD II (WA50040A, WA50042A, WA50050A, WA50052A)HET · Special | Olympus Winter & Ibe GmbH | 08/29/2019SE |
More from Olympus Winter & Ibe GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230)HET · Traditional | 08/29/2025SE |
Questions and answers
When was SIRIUS Endoscope System cleared by the FDA?
SIRIUS Endoscope System (K221642) received a 510(k) decision of Substantially Equivalent on December 12, 2022, 189 days after the submission was received.
What is the product code of K221642?
The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.