Serafin®
K-Number: K251758 · 2025-09-11
ApplicantTns Co., Ltd.
Decision Date2025-09-11
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Serafin® is a medical device manufactured by Tns Co., Ltd.. It received FDA 510(k) clearance on 2025-09-11 under approval number K251758. 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 2025-09-11. It is manufactured by Tns Co., Ltd.. The 510(k) number is K251758.
When was Serafin® approved by the FDA?
Serafin® received FDA 510(k) clearance on 2025-09-11, under approval number K251758.
What company makes Serafin®?
Serafin® is manufactured by Tns Co., Ltd..
What is the FDA product code for Serafin®?
The FDA product code for Serafin® is NXC.
Other Devices by Tns Co., Ltd.
Related Devices (Code: NXC)
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.