da Vinci Surgical System, Model IS5000
Intuitive Surgical, Inc. · 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, Inc.
- Decision date
- 2026-09-08
- Decision code
- SESE
- Country code
- US
- Device name
- da Vinci Surgical System, Model IS5000
- Advisory committee
- GU
- Contact
- Changxin Xu
- K number
- K261823
- State
- CA
- Date received
- 2026-06-01
- 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
- 8043903, 3009161688, 3008309062, 3044545674, 2029275, 3004111573, 3014644276, 3013283620, 3015895145, 3026606306, 3015612252, 8010877, 3013077751, 3010885402, 2936485, 2955842, 3007029079, 1650907, 2032098, 3042940623, 3009941480, 3004784537, 9614969, 3031594238, 3018126215, 3033043422, 3017820152, 3012627460, 3001592626, 3048246462, 1531174, 1226146, 3016832577, 1061124, 3013665681, 2246552, 1058584, 3038188839, 3022626486, 9681503 +58 more
- FEI number
- 3009161688, 3008309062, 3044545674, 3004111573, 3013283620, 3015895145, 3026606306, 3015612252, 3013077751, 3010885402, 2936485, 3007029079, 1000160458, 3042940623, 3006149253, 3009941480, 3004784537, 1000512168, 3002807793, 3031594238, 3018126215, 3002914049, 3033043422, 3017820152, 3012627460, 3002808088, 3002807095, 3001592626, 3002680121, 3048246462, 3016832577, 3013665681, 2246552, 1000499348, 3038188839, 3022626486, 3010193531, 3042953929, 3010564249, 3013868968 +58 more