K260514

Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle

510(k) number: K260514
Device name: Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
Applicant: CMT Health PTE., Ltd. SG
Product code: FMF — Syringe, Piston
Decision date: 2026-06-12
Date received: 2026-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General Hospital

Also available from FDA: K260514.pdf

Official FDA record: K260514

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.