K253268
- 510(k) number
- K253268
- Device name
- Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap
- Applicant
- CMT Health PTE., Ltd. SG
- Product code
- PNR — Enteral Syringes With Enteral Specific Connectors
- Decision date
- 2026-04-08
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K253268.pdf
Official FDA record: K253268
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.