Profoject LOR Syringe— 510(k) K261372
Substantially EquivalentCMT Health PTE., Ltd.
FDA 510(k) clearance K261372 for Profoject LOR Syringe, Substantially Equivalent on 2026-09-25. Applicant: CMT Health PTE., Ltd.. Device class: 2.
Clearance details
- Applicant
- CMT Health PTE., Ltd.
- Product code
- Code CAZ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5140
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code CAZ
view allMore clearances from CMT Health PTE., Ltd.
view all- K262215 — Profoject Safety Sliding Blood Collection Set
- K261829 — Profoject Dual-Safety Pen Needles
- K260739 — Profoject Pen Needles (Model A; Model B)
- K260514 — Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle
- K260855 — Profoject Safety Pen Needles
Adverse events under product code CAZ
product code CAZ- Injury
- 145
- Malfunction
- 942
- Other
- 1
- Total
- 1,088
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.