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FDA 510(k)

Kronos Electrocautery Device

K-Number: K232805 · 2024-04-25

Decision Date2024-04-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Kronos Electrocautery Device is a medical device manufactured by Single Pass, Inc.. It received FDA 510(k) clearance on 2024-04-25 under approval number K232805. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kronos Electrocautery Device?

Kronos Electrocautery Device is a medical device that received FDA 510(k) clearance on 2024-04-25. It is manufactured by Single Pass, Inc.. The 510(k) number is K232805.

When was Kronos Electrocautery Device approved by the FDA?

Kronos Electrocautery Device received FDA 510(k) clearance on 2024-04-25, under approval number K232805.

What company makes Kronos Electrocautery Device?

Kronos Electrocautery Device is manufactured by Single Pass, Inc..

What is the FDA product code for Kronos Electrocautery Device?

The FDA product code for Kronos Electrocautery Device is GEI.

Other Devices by Single Pass, Inc.

Related Devices (Code: GEI)

Official Source

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