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FDA 510(k)

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

K-Number: K212355 · 2021-08-26

ApplicantCheckpoint Surgical
Decision Date2021-08-26
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large is the device name listed in this FDA 510(k) record. The listed applicant is Checkpoint Surgical. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K212355. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large?

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Checkpoint Surgical. The 510(k) number is K212355.

When did Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large receive FDA 510(k) clearance?

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large received FDA 510(k) clearance on 2021-08-26, under 510(k) number K212355.

Who is the listed applicant for Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large?

The FDA 510(k) record lists Checkpoint Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large?

The FDA product code for Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large is ETN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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