FDA 510(k)

MTS 지포티딘 0.016-256 µg/mL

K-번호: K260696 · 2026-04-17

결정일2026-04-17

제품 코드JWY

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

MTS Gepotidacin 0.016-256 µg/mL is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem s.r.l.. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K260696. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MTS Gepotidacin 0.016-256 µg/mL?

MTS Gepotidacin 0.016-256 µg/mL is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Liofilchem s.r.l.. The 510(k) number is K260696.

When did MTS Gepotidacin 0.016-256 µg/mL receive FDA 510(k) clearance?

MTS Gepotidacin 0.016-256 µg/mL received FDA 510(k) clearance on 2026-04-17, under 510(k) number K260696.

Who is the listed applicant for MTS Gepotidacin 0.016-256 µg/mL?

The FDA 510(k) record lists Liofilchem s.r.l. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MTS Gepotidacin 0.016-256 µg/mL?

The FDA product code for MTS Gepotidacin 0.016-256 µg/mL is JWY.

Liofilchem s.r.l.를 신청인으로 등재한 기타 기록

K252114MTS 아즈트레온아박타마 0.016/4 - 256/4 µg/mL K251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)K243202MTS 세프토비프롤 0.002-32 µg/mL K230479ComASP 세피디로콜 0.008-128 K211672MTS 피퍼아실린-타조바쿰 0.016/4 - 256/4µg/mL K200180MTS 오마다실린 0.002 - 32 μg/mL

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