510(k) clearance
ENDOFLATOR+; Smart Smoke Evacuation
- 510(k) number
- K260209
- Applicant
- Karl Storz SE & CO. KG
- Decision date
- Aug 19, 2026
- Date received
- Jan 23, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- HIF
- Device type
- Insufflator, Laparoscopic
- Device class
- Class II
- Regulation
- 21 CFR 884.1730
- Advisory committee
- Obstetrics/Gynecology
- Statement or summary
- Summary
- Third party
- N
- Location
- Tuttlingen, DE