FDA 510(k)

Serafin®

K-Number: K232074 · 2024-02-22

Decision Date2024-02-22

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Serafin® is the device name listed in this FDA 510(k) record. The listed applicant is Tns Co., Ltd.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K232074. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Serafin®?

Serafin® is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Tns Co., Ltd.. The 510(k) number is K232074.

When did Serafin® receive FDA 510(k) clearance?

Serafin® received FDA 510(k) clearance on 2024-02-22, under 510(k) number K232074.

Who is the listed applicant for Serafin®?

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

What is the FDA product code for Serafin®?

The FDA product code for Serafin® is NXC.

Other records listing Tns Co., Ltd. as applicant

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.

K251758Serafin®

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.