K243821
- 510(k) number
- K243821
- Device name
- i-Cut
- Applicant
- A.M.I. Agency For Medical Innovations GmbH AT
- Product code
- HET — Laparoscope, Gynecologic (And Accessories)
- Decision date
- 2025-04-25
- Date received
- 2024-12-12
- 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: K243821.pdf
Official FDA record: K243821
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.