NAY — System, Surgical, Computer Controlled Instrument Class II
FDA product code NAY covers "System, Surgical, Computer Controlled Instrument", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NAY
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260695 | intuitive surgical | da Vinci Firefly Imaging System | May 22, 2026 |
| K254192 | asensus surgical | Senhance Ultrasonic System | May 12, 2026 |
| K253986 | intuitive surgical | da Vinci Force Feedback Instruments | March 11, 2026 |
| K253556 | intuitive surgical | da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator | January 16, 2026 |
| K251739 | intuitive surgical | da Vinci Surgical System (IS5000) | January 16, 2026 |
| K252675 | intuitive surgical | da Vinci SP Surgical System (SP1098) | December 15, 2025 |
| K252069 | intuitive surgical | da Vinci SP Surgical System (SP1098) | December 2, 2025 |
| K251426 | intuitive surgical | da Vinci SP Surgical System (SP1098) | October 3, 2025 |
| K251817 | intuitive surgical | da Vinci SP Surgical System (SP1098) | September 10, 2025 |
| K251227 | intuitive surgical | da Vinci Surgical System (IS5000) | September 8, 2025 |
| K251324 | intuitive surgical | da Vinci SP Surgical System (SP1098) | August 29, 2025 |
| K252350 | intuitive surgical | da Vinci SP Firefly Imaging System | August 28, 2025 |
| K250442 | intuitive surgical | da Vinci Surgical System, IS5000 | July 29, 2025 |
| K251213 | intuitive surgical | Da Vinci Surgical System (IS5000) | July 23, 2025 |
| K251202 | intuitive surgical | da Vinci Surgical System (IS5000) | July 16, 2025 |
| K250674 | intuitive surgical | Vessel Sealer Curved (480522) | June 13, 2025 |
| K240852 | intuitive surgical | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) | June 11, 2025 |
| K250786 | intuitive surgical | SP Endoscope, 0° (430600) | May 13, 2025 |
| K243714 | intuitive surgical | da Vinci SP Surgical System (SP1098) | April 24, 2025 |
| K242427 | intuitive surgical | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) | April 1, 2025 |