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FDA 510(k)

NITI-S STENT & INTRODUCER, MODEL EOXXXX

K-Number: K041648 · 2005-04-28

ApplicantTaewoong Medical Co., Ltd.
Decision Date2005-04-28
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NITI-S STENT & INTRODUCER, MODEL EOXXXX 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 2005-04-28 under 510(k) number K041648. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITI-S STENT & INTRODUCER, MODEL EOXXXX?

NITI-S STENT & INTRODUCER, MODEL EOXXXX is a medical device that received FDA 510(k) clearance on 2005-04-28. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K041648.

When did NITI-S STENT & INTRODUCER, MODEL EOXXXX receive FDA 510(k) clearance?

NITI-S STENT & INTRODUCER, MODEL EOXXXX received FDA 510(k) clearance on 2005-04-28, under 510(k) number K041648.

Who is the listed applicant for NITI-S STENT & INTRODUCER, MODEL EOXXXX?

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 STENT & INTRODUCER, MODEL EOXXXX?

The FDA product code for NITI-S STENT & INTRODUCER, MODEL EOXXXX is ESW.

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Other records listing Taewoong Medical Co., Ltd. as applicant

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K260962SphincterotomeK252648Niti-S SPAXUS StentK251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentK243619Niti-S Esophageal Stent; Esophageal TTS StentK250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentK223067Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent

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Related Devices (Code: ESW)

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.

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific CorporationK243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston ScientificK233837Agile Esophageal Stent 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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