Product code LYK— Gastroenterology, Urology

FDA has cleared 41 devices under product code LYK between 1983 and 2026, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20261 clearance
• 20251 clearance
• 20061 clearance
• 20051 clearance
• 20021 clearance
• 20011 clearance
• 20001 clearance
• 19971 clearance
• 19953 clearances
• 19942 clearances
• 19936 clearances
• 19922 clearances
• 19915 clearances
• 19907 clearances
• 19891 clearance

• Intertherapy, Inc.3 clearances
• Applied Medical Resources3 clearances
• American Edwards Laboratories3 clearances
• Vena Medical Holdings Corp2 clearances
• Trimedyne, Inc.2 clearances
• Olympus Corp.2 clearances
• KARL STORZ Endoscopy-America, Inc.2 clearances
• Intramed Laboratories, Inc.2 clearances
• Endovascular, Inc.2 clearances
• Cardio-Optics, Inc.2 clearances

• K253842 — Vena MicroAngioscope SystemVena Medical Holdings Corp·2026-01-28
• K251767 — Vena MicroAngioscope SystemVena Medical Holdings Corp·2025-10-01
• K062340 — CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEMCardio-Optics, Inc.·2006-11-30
• K050808 — CORONARY SINUS ACCESS KIT, MODEL KCS8F-01Cardio-Optics, Inc.·2005-07-28
• K011793 — KSEA FIBERSCOPEKARL STORZ Endoscopy-America, Inc.·2002-04-17
• K012724 — SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273Smith & Nephew, Inc.·2001-11-08
• K001408 — KSEA VASCULAR FIBERSCOPESKARL STORZ Endoscopy-America, Inc.·2000-10-30
• K964061 — GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)W. L. Gore & Associates, Inc.·1997-02-20
• K952638 — 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[Baxter Edwards·1995-07-28
• K951721 — APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPEApplied Medical Resources·1995-07-11
• K945591 — APPLIED MEDICAL OPTICAL VALVULOTOMEApplied Medical Resources·1995-02-10
• K941715 — ULTATHIN FLEXIBLE ENDOSCOPETechnology Marketing Group·1994-10-04
• K934696 — ANGIOSCOPEIntramed Laboratories, Inc.·1994-01-18
• K931464 — BAXTER CORONARY ANGIOSCOPE INFLATION DEVICEBaxter Healthcare Corp·1993-10-18
• K930758 — DIAGNOSTIC INTRAVASCULAR CATHETERApplied Medical Resources·1993-09-24
• K931421 — DISPOSABLE STEERABLE ANGIOSCOPEEndovascular, Inc.·1993-06-16
• K926433 — 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45Baxter Edwards·1993-03-23
• K924554 — CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPEClarus Medical Systems, Inc.·1993-02-25
• K923996 — DISPOSABLE VASCULAR ANGIOSCOPEEndovascular, Inc.·1993-01-13
• K905745 — AMETEC MASY MODULAR ANGIOSCOPE SYSTEMAmerican Medical Technology, Inc.·1992-04-23
• K914570 — DISPOSABLE VASCULAR ANGIOSCOPENobles-Lai·1992-01-27
• K913129 — ANGIOLAZ ANGIOSCOPE CATHETERAngiolaz, Inc.·1991-12-27
• K913763 — INTERPRET(TM) CATHETER LINEAR TRANSLATORIntertherapy, Inc.·1991-11-20
• K911090 — OMEGA ANGIOSCOPES (OMEGASCOPES)Omega Universal Technologies, Ltd.·1991-07-31
• K911278 — OLYMPUS AF ANGIOSCOPE SYSTEMOlympus Corp.·1991-07-17
• K905083 — 4.5F IMAGECATH ANGIOSCOPEBaxter Healthcare Corp·1991-06-21
• K902329 — ULTRA-VU ANGIOSCOPEAngiolaz, Inc.·1990-08-22
• K895538 — ANGIOSCOPE W/THE OPTISCOPE-2 INTEGRATED ANGIOSCOPYTrimedyne, Inc.·1990-04-26
• K900305 — INTRAVASCULAR IMAGING SYSTEMSIntertherapy, Inc.·1990-04-20
• K897153 — CVIS INSIGHT IMAGING CATHETERCardiovascular Imaging Systems, Inc.·1990-03-26
• K895159 — INTRAVASCULAR IMAGING SYSTEMIntertherapy, Inc.·1990-03-12
• K894459 — ANGIOSCOPEIntramed Laboratories, Inc.·1990-03-07
• K893816 — HEMOLASER HEMOSCOPEHemolaser Corp.·1990-02-01
• K890047 — VASCUCARE PERCUTANEOUS ANGIOSCOPY DELIVERY SYSTEMVascucare, Inc.·1989-06-20
• K883000 — ACS ANGIOSCOPE GUIDE WIREAdvanced Cardiovascular Systems, Inc.·1988-09-28
• K875108 — ACS CORONARY ANGIOSCOPIC CATHETERAdvanced Cardiovascular Systems, Inc.·1988-09-27
• K860858 — OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPEOlympus Corp.·1986-11-20
• K842481 — AMERICAN EDWARDS MINI-FLEX ANGIOSCOPEAmerican Edwards Laboratories·1984-10-18
• K834547 — ANGIOSCOPY CATHETERAmerican Edwards Laboratories·1984-06-11
• K832698 — ANGIOSCOPY CATHETERAmerican Edwards Laboratories·1983-11-03
• K830084 — ANGIOSCOPETrimedyne, Inc.·1983-06-02