Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large

Stimulator, Nerve

Checkpoint Surgical

The following data is part of a premarket notification filed by Checkpoint Surgical with the FDA for Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large.

Pre-market Notification Details

Device IDK212355
510k NumberK212355
Device Name:Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
ClassificationStimulator, Nerve
Applicant Checkpoint Surgical 6050 Oak Tree Blvd., Suite 360 Independence,  OH  44131
ContactBen Cottrill
CorrespondentBen Cottrill
Checkpoint Surgical 6050 Oak Tree Blvd., Suite 360 Independence,  OH  44131
Product CodeETN  
CFR Regulation Number874.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-29
Decision Date2021-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B13095251 K212355 000

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