Open-surgery electrosurgical handpiece/electrode, bipolar, reprocessed
16 devices GMDN 61818
An open‑surgery electrosurgical handpiece with a bipolar electrode is a sterile, rigid instrument that delivers electrosurgical current directly to tissue for cutting and coagulation during open procedures. It is offered in various shapes such as pen‑type, pistol‑style forceps, pincer forceps, or scissors, and may incorporate irrigation, aspiration, lavage, or smoke evacuation to support its primary function.
These devices are originally single‑use items that have been reprocessed for one additional patient use, so they must meet strict sterility and performance standards before being supplied. Users should be aware that reprocessed devices are subject to specific regulatory requirements governing their cleaning, testing, and labeling to ensure safety and effectiveness.