510(k) K151594
K151594 is an FDA 510(k) premarket notification submitted by Ellipse Technologies, Incorporated for the device "Ellipse Supplemental Instrument Trays". The FDA issued a decision of Substantially Equivalent on January 25, 2016. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Ellipse Technologies, Incorporated has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2016
- Date Received
- June 12, 2015
- Clearance Type
- Abbreviated
- 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