FDA.reportPublic FDA data

GENTUITY, LLC

Matched from indexed company URL: Gentuity, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30115785443011578544GENTUITY, LLC1N2026-01-01142 North Road Suite G Sudbury MA US 01776
30216300973021630097GENTUITY, LLC1N2026-01-0128 Crosby Drive Bedford MA US 01730

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2670981006957363K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO2025-01-31
2670981059696353K230620Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterDQO2023-08-08
2670981375218627K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterNQQ2020-02-20
3024391375218627K192922Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterNQQ2020-02-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQO22025-01-31
NQQ22020-02-20

PMN#

GUDID#