Single Use Injector

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SYNELISA PARIETAL CELL ANTIBODIES

FDA 510(k)

FDA Class 2 ·Immunology

Endoscopic Injection Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

injeTAK Adjustable Tip Needle (DIS199; DIS201)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Sclerotherapy Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DISPOSABLE INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VARICES NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

WILTEK VARICES INJECTION NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OMNI CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VANCE CYSTOSCOPIC

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Luminelle DTx Hysteroscopy System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LASERSONICS LASER CYSTOSCOPE MODEL FCY-6-35

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology