510(k) K261266
K261266 is an FDA 510(k) premarket notification submitted by PENTAMASTER MEDIQ SDN BHD for the device "MOWANA Auto Duo". The FDA issued a decision of Substantially Equivalent on September 17, 2026. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2026
- Date Received
- April 16, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type