FED · Endoscopic Access Overtube, Gastroenterology-Urology
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | FED |
|---|---|
| Device Name | Endoscopic Access Overtube, Gastroenterology-Urology |
| 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 101)
Showing 20 most recent of 101 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260965 | CVAC Aspiration System | Calyxo, Inc. | Apr 13, 2026 | SESE |
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) | Zhuhai Pusen Medical Technology Co., Ltd. | Apr 6, 2026 | SESE |
| K252572 | Prodeon Urethral Sheath System | Prodeon Medical, Inc. | Oct 7, 2025 | SESE |
| K250128 | Single Use Suction-Evacuation Ureteral Access Sheath | Anhui Happiness Workshop Medical Instruments Co., Ltd. | Sep 19, 2025 | SESE |
| K250132 | Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. | Sep 5, 2025 | SESE |
| K250695 | Single-use Ureteral Access Sheath | Shenzhen HugeMed Medical Technical Development Co., Ltd. | Jul 8, 2025 | SESE |
| K251599 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | Jul 3, 2025 | SESE |
| K250585 | LumenaTM Ureteral Access Sheath | Cathegenix (Xiamen) Co., Ltd. | Jun 27, 2025 | SESE |
| K250452 | CoralWell Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) | MacroLux Medical Technology Co., Ltd. | Jun 2, 2025 | SESE |
| K243710 | Disposable ureteral access sheath | Shenzhen Trious Medical Technology Co., Ltd. | Apr 11, 2025 | SESE |
| K250517 | Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 | Boston Scientific Corporation | Mar 21, 2025 | SESE |
| K243820 | Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 | Dornier Medtech America | Jan 31, 2025 | SESE |
| K243025 | Ureteral Access Sheath | Seplou (Zhuhai) Co., Ltd. | Jan 30, 2025 | SESE |
| K242173 | Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) | Coloplast Corp. | Nov 12, 2024 | SESE |
| K243091 | Over-tube (TR-1108A) | Fujifilm Corporation | Nov 1, 2024 | SESE |
| K240167 | Single-use Ureteral Access Sheath | Hunan Vathin Medical Instrument Co., Ltd. | Oct 8, 2024 | SESE |
| K241181 | Disposable Ureteral Guide Sheath | Dongguan Zsr Biomedical Technology Company Limited | Aug 2, 2024 | SESE |
| K240853 | Pathfinder® CR System | Neptune Medical, Inc. | Jun 27, 2024 | SESK |
| K233472 | CVAC Aspiration System + CVAC Image Processor | Calyxo, Inc. | Feb 2, 2024 | SESE |
| K230752 | Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) | FUJIFILM Healthcare Americas Corporation | Sep 15, 2023 | SESE |
Top Applicants
- C.R. Bard, Inc. — 5 clearances
- Boddingtons Plastics, Ltd. — 4 clearances
- Coloplast A/S — 4 clearances
- Neptune Medical, Inc. — 4 clearances
- United States Endoscopy Group, Inc. — 4 clearances
