510(k) K915506
LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT by
United States Endoscopy Group, Inc.
— Product Code GCA
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- March 6, 1992
- Date Received
- December 9, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type