Cleared Special

Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent

K250663 · Taewoong Medical Co., Ltd. · Gastroenterology & Urology
Mar 2025
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K250663 is an FDA 510(k) clearance for the Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent, a Stent, Metallic, Expandable, Duodenal (Class II — Special Controls, product code MUM), submitted by Taewoong Medical Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on March 31, 2025, 26 days after receiving the submission on March 5, 2025. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number K250663 FDA.gov
FDA Decision Cleared SESE
Date Received March 05, 2025
Decision Date March 31, 2025
Days to Decision 26 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MUM — Stent, Metallic, Expandable, Duodenal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3610

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