FDA 510(k)

Ceftobiprole BPR 5 µg Disc

K-Number: K250885 · 2025-06-23

Decision Date2025-06-23

Product CodeJTN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Ceftobiprole BPR 5 µg Disc is a medical device manufactured by Liofilchem, Inc.. It received FDA 510(k) clearance on 2025-06-23 under approval number K250885. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceftobiprole BPR 5 µg Disc?

Ceftobiprole BPR 5 µg Disc is a medical device that received FDA 510(k) clearance on 2025-06-23. It is manufactured by Liofilchem, Inc.. The 510(k) number is K250885.

When was Ceftobiprole BPR 5 µg Disc approved by the FDA?

Ceftobiprole BPR 5 µg Disc received FDA 510(k) clearance on 2025-06-23, under approval number K250885.

What company makes Ceftobiprole BPR 5 µg Disc?

Ceftobiprole BPR 5 µg Disc is manufactured by Liofilchem, Inc..

What is the FDA product code for Ceftobiprole BPR 5 µg Disc?

The FDA product code for Ceftobiprole BPR 5 µg Disc is JTN.

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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.