StealthStation S8 Cranial v2.0
K-Number: K212397 · 2021-12-22
ApplicantMedtronic Navigation
Decision Date2021-12-22
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
StealthStation S8 Cranial v2.0 is a medical device manufactured by Medtronic Navigation. It received FDA 510(k) clearance on 2021-12-22 under approval number K212397. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the StealthStation S8 Cranial v2.0?
StealthStation S8 Cranial v2.0 is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Medtronic Navigation. The 510(k) number is K212397.
When was StealthStation S8 Cranial v2.0 approved by the FDA?
StealthStation S8 Cranial v2.0 received FDA 510(k) clearance on 2021-12-22, under approval number K212397.
What company makes StealthStation S8 Cranial v2.0?
StealthStation S8 Cranial v2.0 is manufactured by Medtronic Navigation.
What is the FDA product code for StealthStation S8 Cranial v2.0?
The FDA product code for StealthStation S8 Cranial v2.0 is HAW.
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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.