Niti-S Biliary Speed D Stent
K-Number: K223626 · 2023-05-26
Device Summary
Frequently Asked Questions
What is the Niti-S Biliary Speed D Stent?
Niti-S Biliary Speed D Stent is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K223626.
When did Niti-S Biliary Speed D Stent receive FDA 510(k) clearance?
Niti-S Biliary Speed D Stent received FDA 510(k) clearance on 2023-05-26, under 510(k) number K223626.
Who is the listed applicant for Niti-S Biliary Speed D 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 Speed D Stent?
The FDA product code for Niti-S Biliary Speed D 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.
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.