510(k) K021672
K021672 is an FDA 510(k) premarket notification submitted by Aomori Olympus Co., Ltd. for the device "PANCREATIC DRAINAGE TUBE". The FDA issued a decision of Substantially Equivalent on April 16, 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. Aomori Olympus Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2003
- Date Received
- May 21, 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