FDA 510(k)

Profoject™ LOR Syringe

Número K: K261372 · 2026-09-25

Data da decisão2026-09-25

Código do produtoCAZ

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Profoject™ LOR Syringe is the device name listed in this FDA 510(k) record. The listed applicant is CMT Health PTE., Ltd.. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K261372. The device is classified under product code CAZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Profoject™ LOR Syringe?

Profoject™ LOR Syringe is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is CMT Health PTE., Ltd.. The 510(k) number is K261372.

When did Profoject™ LOR Syringe receive FDA 510(k) clearance?

Profoject™ LOR Syringe received FDA 510(k) clearance on 2026-09-25, under 510(k) number K261372.

Who is the listed applicant for Profoject™ LOR Syringe?

The FDA 510(k) record lists CMT Health PTE., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Profoject™ LOR Syringe?

The FDA product code for Profoject™ LOR Syringe is CAZ.

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Outros registros que listam CMT Health PTE., Ltd. como candidato(a)

K262215Profoject™ Safety Sliding Blood Collection Set K261829Profoject™ Dual-Safety Pen Needles K260739Profoject™ Pen Needles (Model A; Model B)K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety Needle K260855Profoject™ Safety Pen Needles K253268Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap

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Fonte oficial

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