← Product Code [FJL](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FJL) · K960757 # KARL STORZ URETER RESECTOSCOPE (K960757) _KARL STORZ Endoscopy-America, Inc. · FJL · May 1, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FJL/K960757 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [FJL](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FJL.md) - **Decision Date:** May 1, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use The KSEA ureter resectoscope is designed to be used for diagnostic and therapeutic procedures in the transurethral resection of tissue in the ureters and renal pelvis. ## Device Story Manually operated, reusable urological endoscope; used for diagnostic and therapeutic tissue resection in ureters and renal pelvis. Components: 0° straight forward view telescope, working element, sheath, cutting loops, electrodes, cold knife, high frequency cables. Operated by physicians in clinical/surgical settings. Device provides visualization and mechanical/electrosurgical tissue removal. Benefits: minimally invasive access to ureters and renal pelvis for surgical intervention. ## Clinical Evidence No clinical data provided; device relies on design equivalence to existing predicate devices. ## Technological Characteristics Materials: surgical grade stainless steel. Components: 0° telescope, working element, sheath, cutting loops, electrodes, cold knife, high frequency cables. Energy: high frequency (electrosurgical). Form factor: long, rigid endoscopic instrument. Sterilization: reusable (requires reprocessing). ## Regulatory Identification An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Special Controls *Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. ## 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} KSEA 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500 Toll Free 800 421 0837 Fax 310 410 5527 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS MAY - 1 1996 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 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 K960757 Contact: Betty M. Johnson Manager, Regulatory Affairs Device Identification: Common Name Resectoscope Trade Name Karl Storz Ureter Resectoscope Indication: The KSEA ureter resectoscope is designed to be used for diagnostic and therapeutic procedures in the transurethral resection of tissue in the ureters and renal pelvis. Device Description: The KSEA ureter resectoscope is a manually operated, reusable surgical device consisting of a straight forward view telescope (0°), a working element, a sheath, cutting loops, electrodes, a cold knife and high frequency cables. The instrument is long enough to gain access to the surgical area and is designed to be used as an urological endoscope. The body contact materials are surgical grade stainless steel. Substantial Equivalence: The KSEA ureter resectoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in dimensions between the KSEA ureter resectoscope 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: Betty M. Johnson Manager, Regulatory Affairs 000095 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FJL/K960757](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FJL/K960757) **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. 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