510(k) K260514
K260514 is an FDA 510(k) premarket notification submitted by CMT Health PTE., Ltd. for the device "Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle". The FDA issued a decision of Substantially Equivalent on June 12, 2026. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. CMT Health PTE., Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2026
- Date Received
- February 17, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type