Olympus Winter & Ibe GmbH

Olympus Winter & Ibe GmbH specializes in endoscopic medical devices, including single-use and reusable electrosurgical electrodes (both bipolar and monopolar), reusable rigid endoscopic forceps for tissue manipulation, endoscope sheaths, obturators, endoscope assembly adaptors, and dissection forceps. These devices are designed for precision in surgical procedures, particularly within endoscopy.

The company is based in the United States. This location is relevant for regulatory compliance, manufacturing oversight, and distribution of their devices.

Olympus Winter & Ibe GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to identify and verify specific devices.

The company’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.