Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K251123 · 2025-12-29

ApplicantTaewoong Medical Co., Ltd.
Decision Date2025-12-29
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

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

When was Niti-S Biliary Stent; Niti-S Biliary Slim M Stent approved by the FDA?

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

What company makes Niti-S Biliary Stent; Niti-S Biliary Slim M Stent?

Niti-S Biliary Stent; Niti-S Biliary Slim M Stent is manufactured by Taewoong Medical Co., Ltd..

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.

Related Clinical Trials

NCT07607353 Biodegradable Stents in Primary Sclerosing Cholangitis RECRUITING NCT05546372 Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma RECRUITING NCT05874934 Endoscopic Drainage of Presumed Resectable pCCA Using an Intrahepatic Plastic Stent With Retrieval String COMPLETED NCT07606430 Comparison of a Short Modified Metal Stent Versus Plastic Stent as a Bridge to Surgery in Pancreatic Cancer With Malignant Biliary Obstruction NOT_YET_RECRUITING NCT06750146 Hot AXIOS™ for Bile Duct Drainage in Malignant Stenosis SUSPENDED NCT06375967 EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) SUSPENDED

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

View all 10 devices →

Related Devices (Code: FGE)

K163018Zilver 635 Biliary StentCook Ireland, Ltd. K162404Express SD Biliary Monorail Premounted Stent SystemBoston Scientific Corporation K161203Soehendra Stent RetrieverWilson-Cook Medical, Inc. K150487X-Suit NIR Biliary Metallic StentMedinol, Ltd. K171548Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation CatheterWilson-Cook Medical, Inc. K172520CRE RX Biliary Balloon Dilatation CatheterBoston 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.

↑