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

FDA 510(k)

Niti-S Biliary Slim M Stent

K-Number: K221071 · 2022-06-09

Decision Date2022-06-09
Product CodeFGE
Advisory CommitteeGU
DecisionUnknown

Device Summary

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 2022-06-09 under 510(k) number K221071. 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 Slim M Stent?

Niti-S Biliary Slim M Stent is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K221071.

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

Niti-S Biliary Slim M Stent received FDA 510(k) clearance on 2022-06-09, under 510(k) number K221071.

Who is the listed applicant for 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 Slim M Stent?

The FDA product code for 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

View on FDA Database →

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