K230326
- 510(k) number
- K230326
- Device name
- ENFit to ENFit Extension Sets
- Applicant
- Vesco Medical OH · US
- Product code
- PIF — Gastrointestinal Tubes With Enteral Specific Connect
- Decision date
- 2023-11-02
- Date received
- 2023-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K230326.pdf
Official FDA record: K230326
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.