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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Bibbinstruments AB. It received FDA 510(k) clearance on 2023-03-29 under 510(k) 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. The listed applicant is Bibbinstruments AB. The 510(k) number is K212423.

When did EndoDrill® Model X receive FDA 510(k) clearance?

EndoDrill® Model X received FDA 510(k) clearance on 2023-03-29, under 510(k) number K212423.

Who is the listed applicant for EndoDrill® Model X?

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

What is the FDA product code for EndoDrill® Model X?

The FDA product code for EndoDrill® Model X is FCG.

Related Devices (Code: FCG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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