LYK — Angioscope Class II
FDA product code LYK covers "Angioscope", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LYK
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253842 | vena medical holdings | Vena MicroAngioscope System | January 28, 2026 |
| K251767 | vena medical holdings | Vena MicroAngioscope System | October 1, 2025 |
| K062340 | cardio-optics | CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM | November 30, 2006 |
| K050808 | cardio-optics | CORONARY SINUS ACCESS KIT, MODEL KCS8F-01 | July 28, 2005 |
| K011793 | karl storz endoscopy-america | KSEA FIBERSCOPE | April 17, 2002 |
| K012724 | smith and nephew | SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 | November 8, 2001 |
| K001408 | karl storz endoscopy-america | KSEA VASCULAR FIBERSCOPES | October 30, 2000 |
| K964061 | w. l. gore and associates | GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) | February 20, 1997 |
| K952638 | baxter edwards | 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE | July 28, 1995 |
| K951721 | applied medical resources | APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPE | July 11, 1995 |
| K945591 | applied medical resources | APPLIED MEDICAL OPTICAL VALVULOTOME | February 10, 1995 |
| K941715 | technology marketing group | ULTATHIN FLEXIBLE ENDOSCOPE | October 4, 1994 |
| K934696 | intramed laboratories | ANGIOSCOPE | January 18, 1994 |
| K931464 | baxter healthcare | BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE | October 18, 1993 |
| K930758 | applied medical resources | DIAGNOSTIC INTRAVASCULAR CATHETER | September 24, 1993 |
| K931421 | endovascular | DISPOSABLE STEERABLE ANGIOSCOPE | June 16, 1993 |
| K926433 | baxter edwards | 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 | March 23, 1993 |
| K924554 | clarus medical systems | CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE | February 25, 1993 |
| K923996 | endovascular | DISPOSABLE VASCULAR ANGIOSCOPE | January 13, 1993 |
| K905745 | american medical technology | AMETEC MASY MODULAR ANGIOSCOPE SYSTEM | April 23, 1992 |