510(k) K180964
K180964 is an FDA 510(k) premarket notification submitted by Intuitive Surgical, Inc. for the device "Endoscope Sterilization Tray". The FDA issued a decision of Substantially Equivalent on Sep 28, 2018. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Intuitive Surgical, Inc. has 196 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 28, 2018
- Date Received
- Apr 12, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type
- 510(k)