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FDA 510(k)

Uni-port

K-Number: K232062 · 2024-01-16

ApplicantDalim Medical Corp.
Decision Date2024-01-16
Product CodeOTJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Uni-port is the device name listed in this FDA 510(k) record. The listed applicant is Dalim Medical Corp.. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K232062. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Uni-port?

Uni-port is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Dalim Medical Corp.. The 510(k) number is K232062.

When did Uni-port receive FDA 510(k) clearance?

Uni-port received FDA 510(k) clearance on 2024-01-16, under 510(k) number K232062.

Who is the listed applicant for Uni-port?

The FDA 510(k) record lists Dalim Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uni-port?

The FDA product code for Uni-port is OTJ.

Related Devices (Code: OTJ)

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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