EW10-EC02 Endoscopy Support Program

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SKOUT system

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SKOUT® system

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MAGENTIQ-COLO (ME-APDS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius System 100 and GI Genius System 200

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EndoScreener

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CADDIE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SKOUT® system

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GI Genius

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYSTEMS INTEGRATION MODEL: ENDOALPHA

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIVEN DIAGNOSTICS SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SMALL INTESTINAL VIDEOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Smith+Nephew INTELLIO Tablet

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MIROCAM CAPSULE ENDOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology