510(k) K222542
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2022
- Date Received
- August 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type