FDA.reportPublic FDA data

FINEMEDIX

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30120424393012042439FINEMEDIX1N2026-01-01140-9, Yuram-ro, Dong-gu Daegu Gwangyeogsi KR 41059

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2153011874351986K251478ClearTip TBNA TypeKTI2026-04-16
2153011761333862K250994ClearTip FNA and FNB TypesFCG2025-08-21
2153011137475548K242857ClearHemograsperKGE2025-05-21
2153011034171329K242134ClearCap Distal AttachmentOCX2024-08-20
2153011837110595K231267ClearTipFCG2023-06-30
2153011562792354K202616ClearCap Distal AttachmentOCX2021-02-19
2153011712557577K200217ClearEndoclipPKL2020-10-05
2153011860831626K183289ClearGrasp SnareFDI2019-03-06
2153011862874134K183021ClearEndoclipPKL2019-06-28
2153011082315726K181690Clear-Jet Injection CatheterFBK2018-12-21
2153011754232744K180363Clear-Tip EUS-FNAFCG2018-11-01
2153011290701923
2153011503251845

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FCG32025-08-21
OCX22024-08-20
PKL22020-10-05
KTI12026-04-16
KGE12025-05-21
FDI12019-03-06
FBK12018-12-21