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FDA 510(k)

CYGNUS-C Standalone ACIF System

K-Number: K222041 · 2023-02-09

ApplicantGS Medical Co., Ltd.
Decision Date2023-02-09
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CYGNUS-C Standalone ACIF System is a medical device manufactured by GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-02-09 under approval number K222041. 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 CYGNUS-C Standalone ACIF System?

CYGNUS-C Standalone ACIF System is a medical device that received FDA 510(k) clearance on 2023-02-09. It is manufactured by GS Medical Co., Ltd.. The 510(k) number is K222041.

When was CYGNUS-C Standalone ACIF System approved by the FDA?

CYGNUS-C Standalone ACIF System received FDA 510(k) clearance on 2023-02-09, under approval number K222041.

What company makes CYGNUS-C Standalone ACIF System?

CYGNUS-C Standalone ACIF System is manufactured by GS Medical Co., Ltd..

What is the FDA product code for CYGNUS-C Standalone ACIF System?

The FDA product code for CYGNUS-C 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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