EndoDrill® Model X
K-Number: K212423 · 2023-03-29
ApplicantBibbinstruments AB
Decision Date2023-03-29
Product CodeFCG
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
EndoDrill® Model X is a medical device manufactured by Bibbinstruments AB. It received FDA 510(k) clearance on 2023-03-29 under approval number K212423. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EndoDrill® Model X?
EndoDrill® Model X is a medical device that received FDA 510(k) clearance on 2023-03-29. It is manufactured by Bibbinstruments AB. The 510(k) number is K212423.
When was EndoDrill® Model X approved by the FDA?
EndoDrill® Model X received FDA 510(k) clearance on 2023-03-29, under approval number K212423.
What company makes EndoDrill® Model X?
EndoDrill® Model X is manufactured by Bibbinstruments AB.
What is the FDA product code for EndoDrill® Model X?
The FDA product code for EndoDrill® Model X is FCG.
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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.