FDA.reportPublic FDA data

Tusker-Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121303353012130335Tusker Medical Inc.1N2026-01-017000 W. William Cannon Dr. Suite 110 Austin TX US 78735

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2397201170614567P190016Tula® SystemQJA2019-11-25
2397201975252638K252436Tula Tympanostomy Tube Delivery DeviceETD2026-04-23

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ETD12026-04-23
QJA12019-11-25

PMA#

Tula® System

2022-12-15

Tusker Medical, Inc.155 Jefferson Drive, Suite 200menlo Park, CA 94025 PMA NumberP190016 Supplement NumberS006 Date Received09/22/2022 Decision Date12/15/2022 Product Code QJA  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement...

Tula® System

2022-09-22

Tusker Medical, Inc.155 Jefferson Drive, Suite 200menlo Park, CA 94025 PMA NumberP190016 Supplement NumberS005 Date Received08/24/2022 Decision Date09/22/2022 Product Code QJA  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Rea...

PMN#