K260209
- 510(k) number
- K260209
- Device name
- ENDOFLATOR+; Smart Smoke Evacuation
- Applicant
- Karl Storz SE & CO. KG DE
- Product code
- HIF — Insufflator, Laparoscopic
- Decision date
- 2026-08-19
- Date received
- 2026-01-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K260209.pdf
Official FDA record: K260209
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.