KARL STORZ URETER RESECTOSCOPE
Device Facts
| Record ID | K960757 |
|---|---|
| Device Name | KARL STORZ URETER RESECTOSCOPE |
| Applicant | KARL STORZ Endoscopy-America, Inc. |
| Product Code | FJL · Gastroenterology, Urology |
| Decision Date | May 1, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| 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).
Indications for Use
Indicated for diagnostic and therapeutic transurethral resection of tissue in the ureters and renal pelvis in patients requiring urological endoscopic intervention.
Regulatory Classification
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.
Related Devices
- K061541 — KSEA BIPOLAR ELECTROTOME · Ksea · Aug 21, 2006
- K233372 — KARL STORZ Fiber Telescopes for Urology · Karl Storz SE & CO. KG · Jul 25, 2024
- K043022 — STRYKER FLEXIBLE CYSTONEPHROSCOPE · Stryker Endoscopy · Mar 15, 2005
- K031278 — STRYKER FLEXIBLE URETEROSCOPE · Stryker Endoscopy · Oct 16, 2003
- K950719 — OES UROLOGY · Olympus America, Inc. · Dec 11, 1996
