510(k) K183616
K183616 is an FDA 510(k) premarket notification submitted by M.I.Tech Co., Ltd. for the device "HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)". The FDA issued a decision of Substantially Equivalent on January 10, 2019. The device falls under product code MQR (Stent, Colonic, Metallic, Expandable), a Class II device regulated under 21 CFR 878.3610. M.I.Tech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 2019
- Date Received
- December 26, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stent, Colonic, Metallic, Expandable
- Device Class
- Class II
- Regulation Number
- 878.3610
- Review Panel
- GU
- Submission Type