510(k) K023666
K023666 is an FDA 510(k) premarket notification submitted by Rusch Intl. for the device "RUSCH GUIDED CHOLANGIOGRAPHY CATHETER". The FDA issued a decision of Substantially Equivalent on June 17, 2003. The device falls under product code FGE (Stents, Drains And Dilators For The Biliary Ducts), a Class II device regulated under 21 CFR 876.5010. Rusch Intl. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2003
- Date Received
- October 31, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stents, Drains And Dilators For The Biliary Ducts
- Device Class
- Class II
- Regulation Number
- 876.5010
- Review Panel
- GU
- Submission Type