FDA.reportPublic FDA data

TAEWOONG MEDICAL CO., LTD

Matched from indexed company URL: Taewoong Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30039029433003902943TAEWOONG MEDICAL CO., LTD1N2026-01-0114 Gojeong-ro, Wolgot-myeon Gimpo-Si Gyeonggi KR 10022
30112770673011277067Taewoong Medical USA1Y2026-01-014801 Wilshire Blvd Ste 102 Los Angeles CA US 90010

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
213862058402186K260962SphincterotomeKNS2026-05-21
213861854224888K252648Niti-S SPAXUS StentPCU2026-03-13
213861145219013K251123Niti-S Biliary Stent; Niti-S Biliary Slim M StentFGE2025-12-29
213861978196525K250663Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort StentMUM2025-03-31
213861270715775K243619Niti-S Esophageal Stent; Esophageal TTS StentESW2025-10-30
213861244788267K240522Esophageal TTS StentESW2024-03-22
213861361980360K223626Niti-S Biliary Speed D StentFGE2023-05-26
213861386512992K223256Optimos™ CystotomeKNS2023-04-05
213861483594715K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort StentMUM2023-06-14
213861349795402K221482Esophageal TTS StentESW2022-06-22
213861408312257K221071Niti-S Biliary Slim M StentFGE2022-06-09
213861645436912K211706Esophageal TTS StentESW2021-10-08
213861771060515K123205ESOPHAGEAL TTS STENTESW2013-10-09
213861887342025K113551ESOPHAGEAL TTS STENTESW2012-02-14
213861603307879K080782NITI-S ESOPHAGEAL STENTESW2009-01-30
213861835993318K073667NITI-S BILIARY STENTFGE2008-11-19
213862044438375K041648NITI-S STENT & INTRODUCER, MODEL EOXXXXESW2005-04-28
213861445061977
213861506240448
213862057973114

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ESW82025-10-30
FGE42025-12-29
KNS22026-05-21
MUM22025-03-31
PCU12026-03-13

PMN#