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FDA 510(k)

Niti-S SPAXUS Stent

K-Number: K252648 · 2026-03-13

ApplicantTaewoong Medical Co., Ltd.
Decision Date2026-03-13
Product CodePCU
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Niti-S SPAXUS 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 2026-03-13 under 510(k) number K252648. The device is classified under product code PCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Niti-S SPAXUS Stent?

Niti-S SPAXUS Stent is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K252648.

When did Niti-S SPAXUS Stent receive FDA 510(k) clearance?

Niti-S SPAXUS Stent received FDA 510(k) clearance on 2026-03-13, under 510(k) number K252648.

Who is the listed applicant for Niti-S SPAXUS 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 SPAXUS Stent?

The FDA product code for Niti-S SPAXUS Stent is PCU.

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.

K260962SphincterotomeK251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentK243619Niti-S Esophageal Stent; Esophageal TTS StentK250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentK240522Esophageal TTS StentK223067Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent

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Related Devices (Code: PCU)

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.

K220112AXIOS Stent and Electrocautery-Enhanced Delivery SystemBoston Scientific CorporationK203132AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific CorporationK192043AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific CorporationK181905AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific CorporationK163272AXIOS Stent and Electrocautery Enhanced Delivery SystemBoston Scientific Corporation

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.

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