510(k) K232157
- Device
- Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control
- Applicant
- Stryker Corporation
- 510(k) number
- K232157
- Product code
- GCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-18
- Date received
- 2023-07-20
- Regulation
- 876.1500
- Classification name
- Laparoscope, General & Plastic Surgery
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Janki Bhatt
- Address
- 5900 Optical Ct. San Jose CA US 95138 95138
FDA Registration Numbers
- 1423537
- 9681147
- 3003898360
- 3030311186
- 3011373951
- 1519132
- 3010400865
- 3042225166
- 3013700547
- 3005809810
- 3008383115
- 3013002341
- 3011416394
- 2320767
- 3016248634
- 3010400367
- 3011986317
- 1047843
- 2936485
- 2032521
- 1421101
- 3015895045
- 9681191
- 3003713161
- 3006161756
- 3008868758
- 3001675293
- 1054241
- 2245304
- 1928237
- 1000181154
- 3016667340
- 8010273
- 3009134855
- 1032347
- 1219930
- 3008729892
- 3010564249
- 9611665
- 1220477
- 9614969
- 3024137003
- 9611274
- 3010055973
- 9614434
- 3007766601
- 3010273872
- 3010160527
- 3029950834
- 3017102971
- 3003903031
- 3001722928
- 3008386005
- 2085947
- 3004091527
- 3012453745
- 2126670
- 2530138
- 3027500817
- 3011230048
- 3018126215
- 1820334
- 3018907196
- 3006990600
- 8043971
- 9612030
- 1061124
- 3006581049
- 3004135191
- 1420032
- 3014769442
- 3003435550
- 3030839824
- 1226146
- 3043152784
- 3012460907
- 3010547268
- 3030733800
- 2320762
Source Documents
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