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510(k) Data Aggregation
K Number
K212355Device Name
Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
Manufacturer
Date Cleared
2021-08-26
(28 days)
Regulation Number
874.1820Why did this record match?
Applicant Name (Manufacturer) :
Checkpoint Surgical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Checkpoint Guardian Intraoperative Lead is a single-use, sterile medical device accessory intended to be used with Checkpoint Stimulators to provide electrical stimulation of exposed motor nerves or muscle tissue to identify nerves and to test nerve and muscle excitability.
Device Description
The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing stimulus to a targeted nerve. The accessories are intended for use with any device from the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a targeted nerve.
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