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The Karl Storz Remorgida forceps are designed to grasp, coagulate and cut tissue during laparoscopic surgical procedures in gynecology, including but not limited to laparoscopic separation of adhesions, laparoscopically assisted vaginal hysterectomy, uretosacral nerve ablation, laparoscopic oophorectomy, laparoscopic ovarian cystectomy and laparoscopic myomectomy.

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 accessorv to a laparoscope. The body contact materials are surgical grade stainless steel and PEEK.

This document is a 510(k) Summary of Safety and Effectiveness for the Karl Storz Remorgida forceps. It does not contain information about acceptance criteria, device performance, a study to prove acceptance, sample sizes, expert qualifications, or ground truth establishment. This is typical for a 510(k) premarket notification as it focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data as would be required for a PMA (Premarket Approval).

Therefore, I cannot fulfill your request for details on acceptance criteria and a study proving device performance based on the provided text. The document states that "minor differences in design and dimensions between the Karl Storz Remorgida forceps and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices." This implies that the performance is considered equivalent to existing, already-approved devices, and thus a new comprehensive performance study to establish new acceptance criteria is not presented here.

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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.

Ask a specific question about this device