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FDA 510(k)

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

K-Number: K250663 · 2025-03-31

Decision Date2025-03-31
Product CodeMUM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-03-31 under 510(k) 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. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K250663.

When did Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent receive FDA 510(k) clearance?

Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent received FDA 510(k) clearance on 2025-03-31, under 510(k) number K250663.

Who is the listed applicant for Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent?

The FDA 510(k) record lists Taewoong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Taewoong Medical Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 12 devices →

Related Devices (Code: MUM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.