(21 days)
The Karl Storz Remorgida forceps are designed to grasp, coagulate and cut tissue during laparoscopic surgical procedures, including but not limited to laparoscopic separation of adhesions, laparoscopically assisted colon resection, laparoscopic appendectomy and Nissen fundoplication.
The Karl Storz Remorgida forceps are a manually operated, reusable surgical device. The instrument features two pairs of forceps in a bipolar configuration and a retractable surgical knife. The device is long enough to gain access to the surgical area and is designed to be used as an accessory to a laparoscope. The body contact materials are surgical grade stainless steel and PEEK.
This document is a 510(k) summary for the Karl Storz Remorgida forceps, a laparoscopic bipolar accessory. It describes the device's indications for use and general specifications, and claims substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance testing, or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory submission requirements for substantial equivalence rather than detailed performance study results.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.