510(k) K170508
K170508 is an FDA 510(k) premarket notification submitted by Intuitive Surgical, Inc. for the device "EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads". The FDA issued a decision of Substantially Equivalent on Mar 10, 2017. 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
- SESE (Substantially Equivalent)
- Decision Date
- Mar 10, 2017
- Date Received
- Feb 21, 2017
- 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).