FDA.reportPublic FDA data

CHECKPOINT SURGICAL INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30122228733012222873CHECKPOINT SURGICAL INC.1N2026-01-016050 Oak Tree Blvd Ste 360 Independence OH US 44131
30455223873045522387CHECKPOINT SURGICAL INC.1N2026-01-016650 W Snowville Rd Ste I Brecksville OH US 44141

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2029361702655642K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, LargeETN2021-08-26
3512971702655642K212355Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, LargeETN2021-08-26
2029361934876263K190246NeuroShieldJXI2019-05-31
3512971934876263K190246NeuroShieldJXI2019-05-31
2029361685173420K150005Checkpoint, Checkpoint Head & NeckETN2015-02-19
3512971685173420K150005Checkpoint, Checkpoint Head & NeckETN2015-02-19
2029361758004266K092292CHECKPOINTETN2009-10-28
3512971758004266K092292CHECKPOINTETN2009-10-28
2029361385249087K061365CHECKPOINT WITH ACCUSTIM TECHNOLOGYETN2006-07-12
3512971385249087K061365CHECKPOINT WITH ACCUSTIM TECHNOLOGYETN2006-07-12
2029361283887390
3512971283887390

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ETN82021-08-26
JXI22019-05-31