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FDA 510(k)

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

K-Number: K230651 · 2023-06-07

ApplicantBecton, Dickinson and Company
Decision Date2023-06-07
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2023-06-07 under 510(k) 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. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K230651.

When did BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) receive FDA 510(k) clearance?

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

Who is the listed applicant for BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)?

The FDA 510(k) record lists Becton, Dickinson and Company as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: 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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