510(k) K182381
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2018
- Date Received
- August 31, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dislodger, Stone, Biliary
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type