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FDA 510(k)

Niti-S Biliary Stent; Niti-S Biliary Slim M Stent

K-Number: K251123 · 2025-12-29

Decision Date2025-12-29
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

Niti-S Biliary Stent; Niti-S Biliary Slim M 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 2025-12-29 under 510(k) number K251123. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Niti-S Biliary Stent; Niti-S Biliary Slim M Stent?

Niti-S Biliary Stent; Niti-S Biliary Slim M Stent is a medical device that received FDA 510(k) clearance on 2025-12-29. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K251123.

When did Niti-S Biliary Stent; Niti-S Biliary Slim M Stent receive FDA 510(k) clearance?

Niti-S Biliary Stent; Niti-S Biliary Slim M Stent received FDA 510(k) clearance on 2025-12-29, under 510(k) number K251123.

Who is the listed applicant for Niti-S Biliary Stent; Niti-S Biliary Slim M 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 Biliary Stent; Niti-S Biliary Slim M Stent?

The FDA product code for Niti-S Biliary Stent; Niti-S Biliary Slim M Stent is FGE.

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: FGE)

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.