NAY — System, Surgical, Computer Controlled Instrument Class II
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 |
|---|---|---|---|
| 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 |
| K243582 | intuitive surgical | da Vinci SP Advanced Access Port Kit (432701) | February 28, 2025 |
| K243641 | intuitive surgical | da Vinci Surgical System (IS5000) | December 16, 2024 |