K250388
- 510(k) number
- K250388
- Device name
- ENDOFLATOR +
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- HIF — Insufflator, Laparoscopic
- Decision date
- 2025-09-22
- Date received
- 2025-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K250388.pdf
Official FDA record: K250388
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.