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FDA 510(k)

AnyPlus Navigated Instruments System

K-Number: K243073 · 2024-12-06

ApplicantGS Medical Co., Ltd.
Decision Date2024-12-06
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AnyPlus Navigated Instruments System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K243073. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AnyPlus Navigated Instruments System?

AnyPlus Navigated Instruments System is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K243073.

When did AnyPlus Navigated Instruments System receive FDA 510(k) clearance?

AnyPlus Navigated Instruments System received FDA 510(k) clearance on 2024-12-06, under 510(k) number K243073.

Who is the listed applicant for AnyPlus Navigated Instruments System?

The FDA 510(k) record lists GS Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AnyPlus Navigated Instruments System?

The FDA product code for AnyPlus Navigated Instruments System is OLO.

Other records listing GS Medical Co., Ltd. as applicant

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Related Devices (Code: OLO)

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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