510(k) K173687
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 15, 2017
- Date Received
- December 1, 2017
- 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