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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 a medical device manufactured by Checkpoint Surgical. It received FDA 510(k) clearance on 2021-08-26 under approval 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. It is manufactured by Checkpoint Surgical. The 510(k) number is K212355.

When was Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large approved by the FDA?

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

What company makes Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large?

Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large is manufactured by Checkpoint Surgical.

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 41302949 Postmarketing Surveillance of Thrombectomy Using a Tron FX Stent Retriever for Large and Medium Vessel Occlusion. Journal of clinical medicine (2025)

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Official Source

View on FDA Database →

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

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