STIEHL TECH

Stiehl Tech specializes in disposable surgical irrigation and aspiration systems, with a focus on pulsatile irrigators. These devices are designed for intraoperative use to help manage fluids during surgical procedures by delivering controlled irrigation and removing debris from the surgical site.

Stiehl Tech is based in the United States. The company develops its devices in compliance with applicable U.S. medical device regulations, ensuring adherence to regulatory standards for surgical irrigation and aspiration systems.

Stiehl Tech’s disposable surgical irrigation and aspiration systems fall under the FDA’s Class II regulatory category. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness.

Yes, Stiehl Tech’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing helps ensure traceability and transparency in the medical device supply chain, allowing for better tracking and compliance verification.