510(k) K070420
K070420 is an FDA 510(k) premarket notification submitted by United States Endoscopy Group, Inc. for the device "BIOSHIELD-ERCP BIOPSY VALVE, MODEL 00711138". The FDA issued a decision of Substantially Equivalent on March 19, 2007. The device falls under product code ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula), a Class II device regulated under 21 CFR 876.1500. United States Endoscopy Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2007
- Date Received
- February 20, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type
To identify stones, tumors, or narrowing in the biliary tree.