FJL · Resectoscope
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | FJL |
|---|---|
| Device Name | Resectoscope |
| Regulation | 21 CFR 876.1500 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
Classification Rationale
(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.
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.
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232486 | KARL STORZ Monopolar Resectoscopes with HF Cable | Karl Storz SE & CO. KG | May 7, 2024 | SESE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF Cable | Karl Storz Endoscopy America, Inc. | Mar 17, 2023 | SESE |
| K230205 | Veloxion System | Corinth Medtech, Inc. | Feb 24, 2023 | SESE |
| K191341 | Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags | Corinth Medtech, Inc. | Jun 13, 2019 | SESE |
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch | Corinth Medtech, Inc. | Mar 15, 2019 | SESE |
| K162979 | Veloxion System | Corinth Medtech, Inc. | Mar 24, 2017 | SESE |
| K102663 | AED RESECTOSCOPE | National Advanced Endoscopy Devices, Inc. | Dec 30, 2010 | SESE |
| K062720 | S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES | Richard Wolf Medical Instruments Corp. | Mar 22, 2007 | SESE |
| K042523 | RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES | Richard Wolf Medical Instruments Corp. | Mar 18, 2005 | SESE |
| K041610 | MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 | Richard Wolf Medical Instruments Corp. | Aug 19, 2004 | SESE |
| K001270 | GYRUS ENDOUROLOGY SYSTEM: AXIPOLAR RESECTOSCOPE LOOP ELECTRODE | Gyrus Medical , Ltd. | Apr 28, 2000 | SESE |
| K971881 | COMEG RESECTOSCOPE AND LASER-RESECTOSCOPE WORKING ELEMENTS/URETHROTOMES/ELECTRODES/ALBARRAB DEFLECTORS | Comeg Endoscopy | Aug 12, 1997 | SESE |
| K964892 | FEMRX TURP SR SYSTEM (TS27XX-YY/TS24XX-YY) | Gynecare Innovation Center | Feb 4, 1997 | SESE |
| K962506 | [SPECIALIZED TISSUE ASPIRATING RESECTOSCOPE (STAR)] | Gynecare Innovation Center | Sep 16, 1996 | SESE |
| K960757 | KARL STORZ URETER RESECTOSCOPE | KARL STORZ Endoscopy-America, Inc. | May 1, 1996 | SESE |
| K954050 | RESECTOSCOPES | KARL STORZ Endoscopy-America, Inc. | Nov 22, 1995 | SESE |
| K952574 | KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS | KARL STORZ Endoscopy-America, Inc. | Jul 20, 1995 | SESE |
| K934835 | FLOVAL | Olympus Corp. | Jun 21, 1994 | SESE |
| K936038 | SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) | Surgical Laser Technologies, Inc. | May 27, 1994 | SESE |
| K934647 | KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION | KARL STORZ Endoscopy-America, Inc. | Feb 9, 1994 | SESE |
Top Applicants
- Corinth Medtech, Inc. — 4 clearances
- KARL STORZ Endoscopy-America, Inc. — 4 clearances
- Olympus Corp. — 3 clearances
- Richard Wolf Medical Instruments Corp. — 3 clearances
- Gynecare Innovation Center — 2 clearances
