FDA.reportPublic FDA data

DANNIK

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30157758373015775837DANNIK1N2026-01-013201 East Colonial Drive Suite M3 Orlando FL US 32803

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2332671846614493K250411DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval SystemGCJ2025-03-12
2332671314578562K211019Disposable Monopolar Laparoscopic Tips and Reusable HandlesGEI2021-10-28
2332671114882795K200053DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only)GCJ2020-04-21
2332671695060193K193019DANNIK Disposable Monopolar Laparoscopic InstrumentGEI2020-03-04
2332671646866248K192711Dannik Titanium Ligation ClipFZP2019-12-20
2332671706616125K192643Dannik Laparoscopic Suction Irrigation SystemGCJ2019-11-19
2332671698424409
2332671587893248

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GCJ32025-03-12
GEI22021-10-28
FZP12019-12-20

PMN#

GUDID#