(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.
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Image /page/0/Picture/0 description: The image shows the Karl Storz Endoscopy logo. The logo is white and black. The words "Karl Storz Endoscopy" are written in a sans-serif font.
Karl Storz Endoscopy-America, Inc
600 C
Curve
110 5527
JUN 1 4 1996
5100 .. SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510() > safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.
Applicant:
Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500
Contact:
Betty M. Johnson Manager, Regulatory Affairs
Device Identification:
Common Name Laparoscopic bipolar accessories
Trade Name Karl Storz Remorgida forceps
Indication: 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.
Device Description: 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.
Substantial Equivalence: The Karl Storz Remorgida forceps are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the Kat! 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.
Signed:
Renate A. Manlucu, Ph.D.
Renate A. MacLaren, Ph.D. Regulatory Affairs Specialist
§ 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.