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PRAXIS MEDICAL LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30159807193015980719PRAXIS MEDICAL LLC1N2026-01-01500 N WILLOW AVE STE 101 Tampa FL US 33606

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2506401326645805K230778EndoCoreKTI2023-09-25
2506401122103781K200278CytoCoreKNW2020-03-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KTI12023-09-25
KNW12020-03-31

PMN#

GUDID#

Praxis Medical - The Praxis Medical CytoCore is a syringe-holding device for performing a biopsy of soft tissue for diagnostic sampling. It is equipped with a scissor-slide mechanism for drawing back the syringe plunger to create suction, and an internal motor which rotates the needle clockwise and counterclockwise motion to facilitate cellular material harvesting. The device places the hand relatively close to the needle tip while the hand is in a position of natural function, providing greater tactile sensation of the texture of the lesion and enabling accurate needle placement using fine motor control of the hand. The device enables an operator to place a needle into a target area to harvest cells.

PRAXIS MEDICAL LLC

2020-08-07