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FDA 510(k)

Sulopenem SPM 2 µg

K-Number: K251879 · 2025-08-12

ApplicantLiofilchem
Decision Date2025-08-12
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sulopenem SPM 2 µg is a medical device manufactured by Liofilchem. It received FDA 510(k) clearance on 2025-08-12 under approval number K251879. 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 Sulopenem SPM 2 µg?

Sulopenem SPM 2 µg is a medical device that received FDA 510(k) clearance on 2025-08-12. It is manufactured by Liofilchem. The 510(k) number is K251879.

When was Sulopenem SPM 2 µg approved by the FDA?

Sulopenem SPM 2 µg received FDA 510(k) clearance on 2025-08-12, under approval number K251879.

What company makes Sulopenem SPM 2 µg?

Sulopenem SPM 2 µg is manufactured by Liofilchem.

What is the FDA product code for Sulopenem SPM 2 µg?

The FDA product code for Sulopenem SPM 2 µg is JTN.

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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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