510(k) K232610
K232610 is an FDA 510(k) premarket notification submitted by Intuitive Surgical, Inc. for the device "da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation". The FDA issued a decision of Substantially Equivalent on March 14, 2024. The device falls under product code NAY (System, Surgical, Computer Controlled Instrument), a Class II device regulated under 21 CFR 876.1500. Intuitive Surgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2024
- Date Received
- August 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Surgical, Computer Controlled Instrument
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
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).