Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent
K-Number: K250663 · 2025-03-31
ApplicantTaewoong Medical Co., Ltd.
Decision Date2025-03-31
Product CodeMUM
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent is a medical device manufactured by Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-03-31 under approval number K250663. The device is classified under product code MUM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent?
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent is a medical device that received FDA 510(k) clearance on 2025-03-31. It is manufactured by Taewoong Medical Co., Ltd.. The 510(k) number is K250663.
When was Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent approved by the FDA?
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent received FDA 510(k) clearance on 2025-03-31, under approval number K250663.
What company makes Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent?
Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent is manufactured by Taewoong Medical Co., Ltd..
What is the FDA product code for Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent?
The FDA product code for Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent is MUM.
Other Devices by Taewoong Medical Co., Ltd.
Related Devices (Code: MUM)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.