Senhance Surgical System
FDA 510(k) K202166 · Transenterix, Inc.
510(k) numberK202166
Submission
- Device name
- Senhance Surgical System
- Applicant
- Transenterix, Inc.
Morrisville, NC, US - Received
- August 3, 2020
- Decision date
- March 2, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | Intuitive Surgical, Inc. | 09/08/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | Intuitive Surgical, Inc. | 07/31/2026SE |
| K260695 | da Vinci Firefly Imaging SystemNAY · Traditional | Intuitive Surgical | 05/22/2026SE |
| K254192 | Senhance Ultrasonic SystemNAY · Traditional | Asensus Surgical | 05/12/2026SE |
| K253986 | da Vinci Force Feedback InstrumentsNAY · Traditional | Intuitive Surgical, Inc. | 03/11/2026SE |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY · Traditional | Intuitive Surgical, Inc. | 01/16/2026SE |
| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | Intuitive Surgical, Inc. | 01/16/2026SE |
| K252675 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 12/15/2025SE |
| K252069 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 12/02/2025SE |
| K251426 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 10/03/2025SE |
More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200049 | Senhance Surgical SystemNAY · Traditional | 03/09/2020SE |
| K192877 | Senhance Surgical SystemNAY · Special | 11/22/2019SE |
| K191482 | Senhance Surgical SystemNAY · Special | 07/11/2019SE |
| K182421 | Senhance Ultrasonic SystemNAY · Traditional | 01/11/2019SE |
| K183098 | Senhance Surgical SystemNAY · Special | 12/06/2018SE |
| K181517 | Senhance Surgical SystemNAY · Traditional | 10/09/2018SE |
| K180163 | TransEnterix Senhance Surgical SystemNAY · Traditional | 05/25/2018SE |
| K171120 | Senhance Surgical Robotic SystemNAY · Traditional | 10/13/2017SE |
| K122299 | Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical…GCJ · Traditional | 10/25/2012SE |
| K120403 | Spider Flexible Blunt Dissector and Band PasserGCJ · Traditional | 04/16/2012SE |
Questions and answers
When was Senhance Surgical System cleared by the FDA?
Senhance Surgical System (K202166) received a 510(k) decision of Substantially Equivalent on March 2, 2021, 211 days after the submission was received.
What is the product code of K202166?
The FDA product code is NAY – System, Surgical, Computer Controlled Instrument, a Class II (moderate risk) device regulated under 21 CFR 876.1500.