Senhance Ultrasonic System
FDA 510(k) K254192 · Asensus Surgical
510(k) numberK254192
Submission
- Device name
- Senhance Ultrasonic System
- Applicant
- Asensus Surgical
Durham, NC, US - Received
- December 23, 2025
- Decision date
- May 12, 2026
- 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).
Other 510(k)s with product code NAY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K251817 | da Vinci SP Surgical System (SP1098)NAY · Traditional | Intuitive Surgical, Inc. | 09/10/2025SE |
More from Intuitive Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233866 | Senhance Surgical SystemNAY · Traditional | 07/19/2024SE |
| K223095 | Senhance Surgical SystemNAY · Traditional | 03/16/2023SE |
| K220889 | Senhance Surgical SystemNAY · Special | 05/27/2022SE |
| K212054 | Senhance Surgical SystemNAY · Traditional | 08/30/2021SE |
| K211325 | Senhance Surgical SystemNAY · Traditional | 07/27/2021SE |
Questions and answers
When was Senhance Ultrasonic System cleared by the FDA?
Senhance Ultrasonic System (K254192) received a 510(k) decision of Substantially Equivalent on May 12, 2026, 140 days after the submission was received.
What is the product code of K254192?
The FDA product code is NAY – System, Surgical, Computer Controlled Instrument, a Class II (moderate risk) device regulated under 21 CFR 876.1500.