← Product Code [FAS](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS) · K961702 # KSEA VAPORIZATION ELECTRODES (K961702) _Karl Storz Endoskop GmbH · FAS · Aug 29, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS/K961702 ## Device Facts - **Applicant:** Karl Storz Endoskop GmbH - **Product Code:** [FAS](/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS.md) - **Decision Date:** Aug 29, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4300 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The KSEA vaporization electrodes are intended to be used to cut prostate tissue, superficial bladder tumors, and to cauterize minor bleeding in the prostate and bladder (hemostasis). ## Device Story Manually operated, single-use endoscopic electrodes; accessory to resectoscopes; used for cutting prostate tissue, superficial bladder tumors, and cauterizing minor bleeding (hemostasis). Operated by surgeons in clinical/surgical settings. Device provides mechanical access to surgical site; electrical energy delivery for tissue vaporization/hemostasis. Benefits include precise tissue removal and bleeding control during urological procedures. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Manually operated, single-use endoscopic instruments; designed as resectoscope accessories; body contact materials with established medical history; provided sterile. ## Regulatory Identification An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator. ## 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} STORZ Karl Storz Endoscopy Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500 Toll Free 800 421 0837 Fax 310 410 5527 K961702 AUG 29 1996 # 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS This summary of 510(k) 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 documents 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 Endoscopic electrodes **Indications:** The KSEA vaporization electrodes are intended to be used to cut prostate tissue, superficial bladder tumors, and to cauterize minor bleeding in the prostate and bladder (hemostasis). **Device Description:** The KSEA vaporization electrodes are manually operated, single-use instruments which are provided sterile to the end-user. The instruments are long enough to gain access to the surgical area, and are designed to be used as accessories to resectoscopes. The body contact materials have a long history of use in medical devices, and do not pose any new issues of safety and effectiveness. **Substantial Equivalence:** The KSEA vaporization electrodes are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and intended uses 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: Betty M. Johnson Manager, Regulatory Affairs 000119 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS/K961702](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FAS/K961702) **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