510(k) K010993
K010993 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "ALIEN RX MICRO CANNULA, MODEL 4530". The FDA issued a decision of Substantially Equivalent on April 30, 2001. The device falls under product code ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula), a Class II device regulated under 21 CFR 876.1500. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2001
- Date Received
- April 3, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
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.