510(k) K250939
- Device
- SIRIUS Endoscope System (PR-SI-1230)
- Applicant
- Precision Robotics (Hong Kong) Limited
- 510(k) number
- K250939
- Product code
- HET
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-08-29
- Date received
- 2025-03-28
- 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
- Alan Kwok
- Address
- Suite 611-612 Lakeside 2 10w, Hong Kong Science Park, New Territories Hong Kong HK
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
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- 3008102042
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- 3024785124
- 3014334038
- 3012494290
- 2320762
- 3031240334
- 3024021261
- 2647580
- 3007156625
- 3004215117
- 1221826
- 1211566
- 3008595179
- 9612501
- 2434839
- 3014615697
- 3013445147
- 3015972753
- 2030598
- 1923569
- 3005049530
- 3009756153
- 3004644065
- 9610617
- 3009380063
- 3019807891
- 3009420598
- 8010047
- 2027111
- 3004608878
- 3010707607
- 9610595
- 2029275
- 9610773
- 1836161
- 2248148
- 9612278
- 3004111573
- 8010456
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- 3020746799
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- 1423714
- 3008837339
- 9614434
- 3003790304
- 3013247477
- 2027009
- 2244478
- 1054241
- 9680721
- 3008571754
- 3004447686
- 2020550
- 1526711
- 3008439467
- 8030607
- 1017294
- 3008494403
- 8043980
- 3009057691
- 3029968414
- 8044057
- 1219602
- 3013023969
- 1219930
- 1424263
- 3014461810
- 3018094310
- 3015976667
- 3003418325
- 1320894
- 8040510
- 3009051888
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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| K200638 | LAP-iX Suction Irrigation | Sejong Medical Co., Ltd. | 2020-04-03 |
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| 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 |