510(k) K202973
K202973 is an FDA 510(k) premarket notification submitted by M.I.Tech Co., Ltd. for the device "HANAROSTENT Benefit Biliary (NNN)". The FDA issued a decision of SESU on May 11, 2021. 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. M.I.Tech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESU ()
- Decision Date
- May 11, 2021
- Date Received
- September 30, 2020
- 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