FDA 510(k)

BD BBL Sensi-Disc Lefamulin 20µg (LMU-20)

K-Number: K230651 · 2023-06-07

Decision Date2023-06-07

Product CodeJTN

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) is a medical device manufactured by Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-06-07 under approval number K230651. 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 BD BBL Sensi-Disc Lefamulin 20µg (LMU-20)?

BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) is a medical device that received FDA 510(k) clearance on 2023-06-07. It is manufactured by Becton, Dickinson and Company. The 510(k) number is K230651.

When was BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) approved by the FDA?

BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) received FDA 510(k) clearance on 2023-06-07, under approval number K230651.

What company makes BD BBL Sensi-Disc Lefamulin 20µg (LMU-20)?

BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) is manufactured by Becton, Dickinson and Company.

What is the FDA product code for BD BBL Sensi-Disc Lefamulin 20µg (LMU-20)?

The FDA product code for BD BBL Sensi-Disc Lefamulin 20µg (LMU-20) is JTN.

Related PubMed Literature

PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024)

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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.