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FDA 510(k)

ETEST Gepotidacin (GEP) (0.016-256 µg/mL)

K-Number: K260447 · 2026-04-21

ApplicantbioMérieux SA
Decision Date2026-04-21
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ETEST Gepotidacin (GEP) (0.016-256 µg/mL) is a medical device manufactured by bioMérieux SA. It received FDA 510(k) clearance on 2026-04-21 under approval number K260447. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETEST Gepotidacin (GEP) (0.016-256 µg/mL)?

ETEST Gepotidacin (GEP) (0.016-256 µg/mL) is a medical device that received FDA 510(k) clearance on 2026-04-21. It is manufactured by bioMérieux SA. The 510(k) number is K260447.

When was ETEST Gepotidacin (GEP) (0.016-256 µg/mL) approved by the FDA?

ETEST Gepotidacin (GEP) (0.016-256 µg/mL) received FDA 510(k) clearance on 2026-04-21, under approval number K260447.

What company makes ETEST Gepotidacin (GEP) (0.016-256 µg/mL)?

ETEST Gepotidacin (GEP) (0.016-256 µg/mL) is manufactured by bioMérieux SA.

What is the FDA product code for ETEST Gepotidacin (GEP) (0.016-256 µg/mL)?

The FDA product code for ETEST Gepotidacin (GEP) (0.016-256 µg/mL) is JWY.

Related Devices (Code: JWY)

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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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