K243527
- 510(k) number
- K243527
- Device name
- High Flow Insufflation Unit (UHI-4)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- HIF — Insufflator, Laparoscopic
- Decision date
- 2025-01-13
- Date received
- 2024-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243527.pdf
Official FDA record: K243527
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.