510(k) K910769
K910769 is an FDA 510(k) premarket notification submitted by Surgitek Medical Engineering Corp. for the device "SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM". The FDA issued a decision of Substantially Equivalent on June 25, 1991. The device falls under product code ODD (Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula), a Class II device regulated under 21 CFR 876.1500. Surgitek Medical Engineering Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 1991
- Date Received
- February 22, 1991
- Clearance Type
- Traditional
- 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.