K232902
- 510(k) number
- K232902
- Device name
- EVA15 insufflator
- Applicant
- Palliare , Ltd. IE
- Product code
- HIF — Insufflator, Laparoscopic
- Decision date
- 2024-05-02
- Date received
- 2023-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232902.pdf
Official FDA record: K232902
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.