FDA.reportPublic FDA data

HISTOSONICS, INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30276645043027664504HISTOSONICS, INC1N2026-01-0116305 36th Avenue North Suite 300 Plymouth MN US 55446

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850006962075HistoSonics - Fluidics Disposable Kit8777400543info@histosonics.com
00850006962082Edison - Treatment Cart8777400543info@histosonics.com
00850006962099Edison - Treatment Head, 12 cm8777400543info@histosonics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3209231581984064K241902Edison SystemQGM2024-10-30
3209231420866164K233466Edison SystemQGM2024-03-13
3209231534111306

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QGM22024-10-30

PMN#

GUDID#