ENDOFLATOR+; Smart Smoke Evacuation
Device Facts
| Record ID | K260209 |
|---|---|
| Device Name | ENDOFLATOR+; Smart Smoke Evacuation |
| Applicant | Karl Storz SE & CO. KG |
| Product Code | HIF · Obstetrics/Gynecology |
| Decision Date | Aug 19, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1730 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
