510(k) K170879
K170879 is an FDA 510(k) premarket notification submitted by Intuitive Surgical, Inc. for the device "IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories". The FDA issued a decision of Substantially Equivalent on Sep 21, 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
- Sep 21, 2017
- Date Received
- Mar 24, 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).