510(k) K223067
K223067 is an FDA 510(k) premarket notification submitted by Taewoong Medical Co., Ltd. for the device "Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent". The FDA issued a decision of Substantially Equivalent on June 14, 2023. The device falls under product code MUM (Stent, Metallic, Expandable, Duodenal), a Class II device regulated under 21 CFR 878.3610. Taewoong Medical Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2023
- Date Received
- September 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stent, Metallic, Expandable, Duodenal
- Device Class
- Class II
- Regulation Number
- 878.3610
- Review Panel
- GU
- Submission Type