da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
Intuitive Surgical · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Sunnyvale
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- 1266 Kifer Rd.
- Statement or summary
- Summary
- Product code
- NAY
- Zip code
- 94086
- Applicant
- Intuitive Surgical
- Decision date
- 2024-05-24
- Decision code
- SESE
- Country code
- US
- Device name
- da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)
- Advisory committee
- GU
- Contact
- Emily Hovick
- K number
- K240723
- State
- CA
- Date received
- 2024-03-18
- Review advisory committee
- SU
- Postal code
- 94086
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- System, Surgical, Computer Controlled Instrument
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.1500
- Device class
- 2
- Registration number
- 3012453745, 3007303113, 3038187466, 3016555232, 3035387162, 1650907, 3008837339, 3003537036, 3015612252, 2029015, 3026606306, 1061124, 3011063460, 3001556604, 3004111573, 3007029079, 3017820152, 3010564249, 2936485, 3022626486, 2246552, 3014635169, 3013665681, 3038188839, 3010684280, 9681503, 9611665, 3007111496, 9614969, 3016607092, 8010877, 3010493171, 3009719225, 1058584, 8043903, 3042953929, 3010193531, 3017619652, 3010860245, 3009941480 +58 more
- FEI number
- 3012453745, 3007303113, 3038187466, 3942, 3006149253, 3016555232, 3035387162, 1000160458, 3002993297, 3008837339, 3003537036, 3015612252, 3026606306, 3011063460, 3001556604, 3004111573, 3007029079, 3017820152, 3010564249, 3002477156, 2936485, 3022626486, 2246552, 3014635169, 3013665681, 3002680121, 3038188839, 3003076831, 3002807793, 3010684280, 3007111496, 1000499348, 3016607092, 3003117688, 3010493171, 3009719225, 3042953929, 3010193531, 3017619652, 3010860245 +58 more