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FDA 510(k)

ENFit Adaptor

K-Number: K233190 · 2024-01-18

Decision Date2024-01-18
Product CodePIO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENFit Adaptor is a medical device manufactured by Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2024-01-18 under approval number K233190. The device is classified under product code PIO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENFit Adaptor?

ENFit Adaptor is a medical device that received FDA 510(k) clearance on 2024-01-18. It is manufactured by Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K233190.

When was ENFit Adaptor approved by the FDA?

ENFit Adaptor received FDA 510(k) clearance on 2024-01-18, under approval number K233190.

What company makes ENFit Adaptor?

ENFit Adaptor is manufactured by Jiangsu Caina Medical Co.,Ltd.

What is the FDA product code for ENFit Adaptor?

The FDA product code for ENFit Adaptor is PIO.

Other Devices by Jiangsu Caina Medical Co.,Ltd

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Related Devices (Code: PIO)

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.