510(k) K242323
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2025
- Date Received
- August 6, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Software Controlled Endoscope And Instrument Holder
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type
To hold and position endoscopes and instruments.