510(k) K254192
- Device
- Senhance Ultrasonic System
- Applicant
- Asensus Surgical
- 510(k) number
- K254192
- Product code
- NAY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-12
- Date received
- 2025-12-23
- Regulation
- 876.1500
- Classification name
- System, Surgical, Computer Controlled Instrument
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Madhuvanthi Soundirarajan
- Address
- 1 Tw Alexander Dr., Suite 160 Durham NC US 27701 27701
FDA Registration Numbers#
- 3012453745
- 1650907
- 3007029079
- 3018126215
- 2955842
- 3015612252
- 9614969
- 1061124
- 3017636737
- 3009217531
- 1531174
- 3004784537
- 3015241782
- 3038284218
- 3013188547
- 3008837339
- 3038188839
- 3009941480
- 8010877
- 3036035332
- 3017119401
- 3014656892
- 1226146
- 2022435
- 8043903
- 3007593944
- 3013942591
- 3014309390
- 3010193531
- 3012880598
- 3002259632
- 2032112
- 3012811961
- 3042953929
- 2029275
- 9681503
- 2936485
- 3033507886
- 1058584
- 3007303113
- 3007084728
- 3018907196
- 3010432890
- 3003537036
- 3011390076
- 3022626486
- 3011459762
- 3016079756
- 2246552
- 3009161688
- 3007111496
- 9611665
- 3003898360
- 3013283620
- 9616517
- 3014644276
- 3014579024
- 3001675293
- 3016096100
- 3031594238
- 8010456
- 3038187466
- 2011171
- 3004111573
- 3001592626
- 3010860245
- 3010564249
- 2032098
- 3015336263
- 3039523130
- 2029015
Source Documents#
Other 510(k) Records For Product Code NAY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260695 | da Vinci Firefly Imaging System | Intuitive Surgical | 2026-05-22 |
| K253986 | da Vinci Force Feedback Instruments | Intuitive Surgical, Inc. | 2026-03-11 |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | Intuitive Surgical, Inc. | 2026-01-16 |
| K251739 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2026-01-16 |
| K252675 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-12-15 |
| K252069 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-12-02 |
| K251426 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-10-03 |
| K251817 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-09-10 |
| K251227 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-09-08 |
| K251324 | da Vinci SP Surgical System (SP1098) | Intuitive Surgical, Inc. | 2025-08-29 |
| K252350 | da Vinci SP Firefly Imaging System | Intuitive Surgical, Inc. | 2025-08-28 |
| K250442 | da Vinci Surgical System, IS5000 | Intuitive Surgical, Inc. | 2025-07-29 |
| K251213 | Da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-07-23 |
| K251202 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2025-07-16 |
| K250674 | Vessel Sealer Curved (480522) | Intuitive Surgical, Inc. | 2025-06-13 |