Karl Storz Wins FDA Nod for Endoflator + Insufflator & Smoke Evacuation System

Karl Storz has received U.S. Food and Drug Administration (FDA) clearance for the Endoflator +, a next-gen insufflator with integrated surgical smoke evacuation system.

An insufflator establishes and maintains a stable working cavity in the body during laparoscopic and robotic procedures using carbon dioxide gas, providing the necessary space to operate. When combined with smoke evacuation, the insufflator preserves image clarity by removing surgical smoke and particulates.

The Endoflator + provides high flow rates and an ULPA filter that helps maintain a smoke-free image, improving visibility and maneuverability. It features CO₂ insufflation up to 50 L/min and integrated smoke evacuation in HF and continuous modes, as well as four procedural modes: high-flow, pediatric, taTME, and EVH.

Proprietary tubing sets offer heated and humidified gas delivery. The tubing is also RFID-enabled for simplicity and safety.

The system can support procedures in general surgery, cardiovascular surgery, colorectal surgery, gynecology, pediatric surgery, proctology, and urology, in both conventional laparoscopic and robotic settings.

“This launch marks a major milestone for KARL STORZ and the healthcare providers we serve,” said Fernando Morales, VP of Surgical & OR Integration at Karl Storz. “The ENDOFLATOR + not only meets high standards of safety and performance but also aligns with new surgical smoke evacuation mandates across multiple states.”

In June, the company won expanded U.S. Food and Drug Administration (FDA) clearance for its AventaMed Solo+ tympanostomy tube device (TTD), allowing its use in pediatric patients aged six months and older.