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FDA 510(k)

QUASAR Standalone ACIF System

K-Number: K231808 · 2023-07-20

ApplicantGS Medical Co., Ltd.
Decision Date2023-07-20
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

QUASAR Standalone ACIF System is a medical device manufactured by GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-07-20 under approval number K231808. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUASAR Standalone ACIF System?

QUASAR Standalone ACIF System is a medical device that received FDA 510(k) clearance on 2023-07-20. It is manufactured by GS Medical Co., Ltd.. The 510(k) number is K231808.

When was QUASAR Standalone ACIF System approved by the FDA?

QUASAR Standalone ACIF System received FDA 510(k) clearance on 2023-07-20, under approval number K231808.

What company makes QUASAR Standalone ACIF System?

QUASAR Standalone ACIF System is manufactured by GS Medical Co., Ltd..

What is the FDA product code for QUASAR Standalone ACIF System?

The FDA product code for QUASAR Standalone ACIF System is OVE.

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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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