510(k) K221642
- Device
- SIRIUS Endoscope System
- Applicant
- Precision Robotics (Hong Kong) Limited
- 510(k) number
- K221642
- Product code
- HET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-12
- Date received
- 2022-06-06
- Regulation
- 884.1720
- Classification name
- Laparoscope, Gynecologic (And Accessories)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Ping Lai Benny Lo
- Address
- Suite 611-612 Lakeside 2, 10w, Hong Kong Science Park,New Territories Hong Kong CN 0000 0000
FDA Registration Numbers
- 3002808148
- 1423662
- 3007789561
- 1057358
- 1825146
- 3019783123
- 1412854
- 9680515
- 1061124
- 3002807315
- 3012507533
- 9614969
- 3008693678
- 3015540957
- 3006546082
- 1018470
- 1216677
- 9612074
- 3025482817
- 3003724334
- 3012460907
- 2032521
- 1720747
- 2649614
- 3008132398
- 3001556604
- 1643264
- 3011050570
- 9610612
- 3010202439
- 3015219237
- 8044098
- 1820334
- 1218882
- 8010877
- 8010298
- 8010487
- 3017636737
- 3021839632
- 1418479
- 9611612
- 2916714
- 8010510
- 3004361445
- 1483278
- 8043746
- 1519132
- 1043214
- 3006554912
- 1055236
- 3014279513
- 3010155661
- 1649518
- 1058584
- 8043903
- 3027454635
- 3009217531
- 3007421149
- 9611503
- 3006787036
- 3011986317
- 1035968
- 3009134855
- 2936485
- 3033043422
- 3014342096
- 3006897899
- 1319639
- 9680837
- 8010418
- 3008044552
- 3012322232
- 9611102
- 3009763019
- 2648623
- 3004491689
- 3013011598
- 9615001
- 3008102042
- 3008386005
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code HET
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250939 | SIRIUS Endoscope System (PR-SI-1230) | Precision Robotics (Hong Kong) Limited | 2025-08-29 |
| K243821 | i-Cut | A.M.I. Agency For Medical Innovations GmbH | 2025-04-25 |
| K210116 | Video Endoscopy System, 3D Video Endoscopy System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2021-10-13 |
| K201832 | Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 | Olympus Medical Systems Corp. | 2021-09-17 |
| K210104 | SurroundScope System | 270surgical , Ltd. | 2021-07-08 |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | Schoelly Fiberoptic GmbH | 2021-03-12 |
| K200216 | 4K UHD Camera System | Scivita Medical Technology Co., Ltd. | 2020-08-21 |
| K200638 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2020-04-03 |
| K190190 | WV1 Endoscope | 270surgical , Ltd. | 2019-11-01 |
| K190744 | ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) | Olympus Winter & Ibe GmbH | 2019-08-29 |
| K172796 | Flex Robotic System and Flex Transabdominal Drive | Medrobotics Corporation | 2018-01-18 |
| K173111 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2017-11-28 |
| K163320 | LAP-Pump PP110 | W.O.M. World of Medicine GmbH | 2017-03-21 |
| K150525 | SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link | KARL STORZ Endoscopy-America, Inc. | 2015-11-20 |
| K151011 | VISERA 4K UHD SYSTEM | Olympus Medical Systems Corp. | 2015-10-01 |