← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K962030 # KARL STORZ REMORGIDA FORCEPS (K962030) _KARL STORZ Endoscopy-America, Inc. · GEI · Jun 14, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K962030 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Jun 14, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use 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 Story Manually operated, reusable laparoscopic bipolar forceps; features dual forceps in bipolar configuration and retractable surgical knife; used as accessory to laparoscope; operated by surgeons in OR; enables simultaneous grasping, coagulation, and cutting of tissue; facilitates minimally invasive procedures; benefits patient via reduced trauma and surgical efficiency. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Materials: surgical grade stainless steel and PEEK. Configuration: bipolar forceps with integrated retractable knife. Operation: manual. Form factor: elongated for laparoscopic access. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K962030 Karl Storz Endoscopy Karl Storz Endoscopy-America, Inc. 600 Corporate Point Chicago, IL 60601 Phone: 312-5527 800 421 0837 10 310 5527 JUN 14 1996 # 510(1) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of 510(1) 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 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. Signed: Renate A. MacLaren, Ph.D. Regulatory Affairs Specialist 00005 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K962030](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K962030) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com