FDA.reportPublic FDA data

GUNZE MEDICAL LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30274199793027419979GUNZE MEDICAL LIMITED1N2026-01-015F, JRE Dojima Tower, 2-4-27, Dojima, Kita-ku Osaka JP 5300003

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3179371535554276K221487NEOVEIL Staple Line ReinforcementOXC2022-08-26
3179371393671745K213498PELNAC Meshed Bilayer Wound MatrixKGN2022-07-14
3179371882968840K191992PELNAC Bilayer Wound MatrixKGN2020-04-29
3179371592980096K130997NEOVEILOXC2013-11-15

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OXC22022-08-26
KGN22022-07-14