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FDA 510(k)

ArtiSential Trocar

K-Number: K212500 · 2021-12-03

ApplicantLivsmed, Inc.
Decision Date2021-12-03
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ArtiSential Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Livsmed, Inc.. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K212500. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArtiSential Trocar?

ArtiSential Trocar is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Livsmed, Inc.. The 510(k) number is K212500.

When did ArtiSential Trocar receive FDA 510(k) clearance?

ArtiSential Trocar received FDA 510(k) clearance on 2021-12-03, under 510(k) number K212500.

Who is the listed applicant for ArtiSential Trocar?

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

What is the FDA product code for ArtiSential Trocar?

The FDA product code for ArtiSential Trocar is GCJ.

Other records listing Livsmed, Inc. as applicant

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Related Devices (Code: GCJ)

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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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