ENDOFLATOR+; Smart Smoke Evacuation— 510(k) K260209
Substantially EquivalentKarl Storz SE & CO. KG
FDA 510(k) clearance K260209 for ENDOFLATOR+; Smart Smoke Evacuation, Substantially Equivalent on 2026-08-19. Applicant: Karl Storz SE & CO. KG. Device class: 2.
Summary
Karl Storz's submission lists ENDOFLATOR+ and Smart Smoke Evacuation, filed under product code HIF, laparoscopic insufflators. The record doesn't describe either beyond the name.
Class II, 21 CFR 884.1730. Obstetrics/Gynecology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Karl Storz filed from Tuttlingen, Germany. The decision came 208 calendar days after receipt (January 23 to August 19, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Karl Storz SE & CO. KG
- Product code
- Product code HIF
- Device class
- Class 2
- Regulation
- 21 CFR 884.1730
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE
Recent devices under product code HIF
view allMore clearances from Karl Storz SE & CO. KG
view allAdverse events under product code HIF
product code HIF- Death
- 19
- Injury
- 578
- Malfunction
- 5,639
- Total
- 6,236
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.