FDA 510(k)

Ultra-Fine™ SAFETY Insulin Syringe

Número K: K260208 · 2026-07-13

Data da decisão2026-07-13

Código do produtoFMF

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ultra-Fine™ SAFETY Insulin Syringe is the device name listed in this FDA 510(k) record. The listed applicant is embecta Medical II, LLC. It received FDA 510(k) clearance on 2026-07-13 under 510(k) number K260208. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ultra-Fine™ SAFETY Insulin Syringe?

Ultra-Fine™ SAFETY Insulin Syringe is a medical device that received FDA 510(k) clearance on 2026-07-13. The listed applicant is embecta Medical II, LLC. The 510(k) number is K260208.

When did Ultra-Fine™ SAFETY Insulin Syringe receive FDA 510(k) clearance?

Ultra-Fine™ SAFETY Insulin Syringe received FDA 510(k) clearance on 2026-07-13, under 510(k) number K260208.

Who is the listed applicant for Ultra-Fine™ SAFETY Insulin Syringe?

The FDA 510(k) record lists embecta Medical II, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultra-Fine™ SAFETY Insulin Syringe?

The FDA product code for Ultra-Fine™ SAFETY Insulin Syringe is FMF.

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Fonte oficial

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