FDA 510(k)

Niti-S SPAXUS Stent

K-Number: K252648 · 2026-03-13

Decision Date2026-03-13

Product CodePCU

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Niti-S SPAXUS Stent is a medical device manufactured by Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-03-13 under approval 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. It is manufactured by Taewoong Medical Co., Ltd.. The 510(k) number is K252648.

When was Niti-S SPAXUS Stent approved by the FDA?

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

What company makes Niti-S SPAXUS Stent?

Niti-S SPAXUS Stent is manufactured by Taewoong Medical Co., Ltd..

What is the FDA product code for Niti-S SPAXUS Stent?

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

Other Devices by Taewoong Medical Co., Ltd.

K211706Esophageal TTS Stent K221482Esophageal TTS Stent K221071Niti-S Biliary Slim M Stent K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent K223626Niti-S Biliary Speed D Stent K223256Optimos Cystotome

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Related Devices (Code: PCU)

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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.