510(k) K202906
K202906 is an FDA 510(k) premarket notification submitted by Schlumbohm GmbH & Co. KG for the device "EndoPilot2". The FDA issued a decision of Substantially Equivalent on April 13, 2021. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2021
- Date Received
- September 29, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type