510(k) clearance

MOWANA™ Auto Duo

FDA 510(k) source

510(k) number

K261266

Applicant

PENTAMASTER MEDIQ SDN BHD

Decision date

Sep 17, 2026

Date received

Apr 16, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

FMI

Device type

Needle, Hypodermic, Single Lumen

Device class

Class II

Regulation

21 CFR 880.5570

Advisory committee

General Hospital

Statement or summary

Summary

Third party

Y

Location

Simpang Ampat, MY