510(k) K200481
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2020
- Date Received
- February 27, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Endoscope Channel Accessory
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To give the endoscope channel additional or improved functionality.