Angioscope
Gastroenterology, Urology · 21 CFR 876.1500
Recent MDR events
7 adverse event reports on file
- PERIVU ANGIOSCOPEJun 7, 2024MalfunctionLemaitre Vascular, Inc.19483789
- 1.7MM 0.8MM 100CM DISPOSABLE ANGIOSCOPESMar 9, 2017MalfunctionApplied Medical Resources2027111-2017-01542
- 2.3MM 1.0MM 80CM DISPOSABLE ANGIOSCOPEOct 11, 2013MalfunctionApplied Medical2027111-2013-00383
- 2.3MM DISPOSABLE ANGIOSCOPEAug 12, 2013MalfunctionApplied MedicalMW5031421
- OLYMPUS EVIS EXERA II XENON LIGHT SOURCEApr 13, 2010MalfunctionOlympus Medical Systems Corporation8010047-2010-00072
- ANGIOSCOPE (DISPOSABLE)Mar 29, 2005MalfunctionEdwards Life ScienceMW1035049
- 2.3MM REUSABLE ANGIOSCOPEMay 10, 1997MalfunctionApplied Medical Resources2027111-1997-00009
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
16 firms currently registered for this product code
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Karl Storz Endovision, Inc.
CHARLTON, MA, US
Vena Medical Holdings Corp.
Kitchener Ontario, CA
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Sterigenics U.s., Llc
Queensbury, NY, US
Myriad Fiber Imaging Technologies, Inc.
DUDLEY, MA, US
Blue Line Sterilization Services
Novato, CA, US
510(k) clearances
41 clearances for this product code
- Vena Medical Holdings CorpJan 28, 2026
K253842 · Vena MicroAngioscope System
- Vena Medical Holdings CorpOct 1, 2025
K251767 · Vena MicroAngioscope System
- Cardio-Optics, Inc.Nov 30, 2006
K062340 · CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
- Cardio-Optics, Inc.Jul 28, 2005
K050808 · CORONARY SINUS ACCESS KIT, MODEL KCS8F-01
- KARL STORZ Endoscopy-America, Inc.Apr 17, 2002
K011793 · KSEA FIBERSCOPE
- Smith & Nephew, Inc.Nov 8, 2001
K012724 · SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
- KARL STORZ Endoscopy-America, Inc.Oct 30, 2000
K001408 · KSEA VASCULAR FIBERSCOPES
- W. L. Gore & Associates, Inc.Feb 20, 1997
K964061 · GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)