510(k) K202571
K202571 is an FDA 510(k) premarket notification submitted by Intuitive Surgical, Inc. for the device "da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories". The FDA issued a decision of Substantially Equivalent - With Limitations on Nov 12, 2020. 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 196 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU (Substantially Equivalent - With Limitations)
- Decision Date
- Nov 12, 2020
- Date Received
- Sep 4, 2020
- 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
- 510(k)
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).