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FDA 510(k)

ENFit Adaptor

K-Number: K233190 · 2024-01-18

ApplicantJiangsu Caina Medical Co.,Ltd
Decision Date2024-01-18
Product CodePIO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENFit Adaptor is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Caina Medical Co.,Ltd. It received FDA 510(k) clearance on 2024-01-18 under 510(k) 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. The listed applicant is Jiangsu Caina Medical Co.,Ltd. The 510(k) number is K233190.

When did ENFit Adaptor receive FDA 510(k) clearance?

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

Who is the listed applicant for ENFit Adaptor?

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

What is the FDA product code for ENFit Adaptor?

The FDA product code for ENFit Adaptor is PIO.

Other records listing Jiangsu Caina Medical Co.,Ltd as applicant

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Related Devices (Code: PIO)

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

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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