LYK · Angioscope
Gastroenterology, Urology · 21 CFR 876.1500 · Class 2
Overview
| Product Code | LYK |
|---|---|
| Device Name | Angioscope |
| 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 41)
Showing 20 most recent of 41 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253842 | Vena MicroAngioscope System | Vena Medical Holdings Corp | Jan 28, 2026 | SESE |
| K251767 | Vena MicroAngioscope System | Vena Medical Holdings Corp | Oct 1, 2025 | SESE |
| K062340 | CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM | Cardio-Optics, Inc. | Nov 30, 2006 | SESE |
| K050808 | CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 | Cardio-Optics, Inc. | Jul 28, 2005 | SESE |
| K011793 | KSEA FIBERSCOPE | KARL STORZ Endoscopy-America, Inc. | Apr 17, 2002 | SESE |
| K012724 | SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 | Smith & Nephew, Inc. | Nov 8, 2001 | SESE |
| K001408 | KSEA VASCULAR FIBERSCOPES | KARL STORZ Endoscopy-America, Inc. | Oct 30, 2000 | SESE |
| K964061 | GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) | W. L. Gore & Associates, Inc. | Feb 20, 1997 | SESE |
| K952638 | 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[ | Baxter Edwards | Jul 28, 1995 | SESE |
| K951721 | APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE | Applied Medical Resources | Jul 11, 1995 | SESE |
| K945591 | APPLIED MEDICAL OPTICAL VALVULOTOME | Applied Medical Resources | Feb 10, 1995 | SESE |
| K941715 | ULTATHIN FLEXIBLE ENDOSCOPE | Technology Marketing Group | Oct 4, 1994 | SESE |
| K934696 | ANGIOSCOPE | Intramed Laboratories, Inc. | Jan 18, 1994 | SESE |
| K931464 | BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE | Baxter Healthcare Corp | Oct 18, 1993 | SESE |
| K930758 | DIAGNOSTIC INTRAVASCULAR CATHETER | Applied Medical Resources | Sep 24, 1993 | SESE |
| K931421 | DISPOSABLE STEERABLE ANGIOSCOPE | Endovascular, Inc. | Jun 16, 1993 | SESE |
| K926433 | 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 | Baxter Edwards | Mar 23, 1993 | SESE |
| K924554 | CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE | Clarus Medical Systems, Inc. | Feb 25, 1993 | SESE |
| K923996 | DISPOSABLE VASCULAR ANGIOSCOPE | Endovascular, Inc. | Jan 13, 1993 | SESE |
| K905745 | AMETEC MASY MODULAR ANGIOSCOPE SYSTEM | American Medical Technology, Inc. | Apr 23, 1992 | SESE |
Top Applicants
- American Edwards Laboratories — 3 clearances
- Applied Medical Resources — 3 clearances
- Intertherapy, Inc. — 3 clearances
- Advanced Cardiovascular Systems, Inc. — 2 clearances
- Angiolaz, Inc. — 2 clearances
