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FDA 510(k)

INNOVERSE Navigation Instruments

K-Number: K241082 · 2024-06-14

ApplicantInnosys Co., Ltd.
Decision Date2024-06-14
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

INNOVERSE Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Innosys Co., Ltd.. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K241082. 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 INNOVERSE Navigation Instruments?

INNOVERSE Navigation Instruments is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Innosys Co., Ltd.. The 510(k) number is K241082.

When did INNOVERSE Navigation Instruments receive FDA 510(k) clearance?

INNOVERSE Navigation Instruments received FDA 510(k) clearance on 2024-06-14, under 510(k) number K241082.

Who is the listed applicant for INNOVERSE Navigation Instruments?

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

What is the FDA product code for INNOVERSE Navigation Instruments?

The FDA product code for INNOVERSE Navigation Instruments is OLO.

Other records listing Innosys Co., Ltd. as applicant

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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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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