Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NTECH CYSTOSCOPES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cystoscope System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CORTEK CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ENDO SMARTCAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

QUANTUM MONO-POLAR ELECTROSURGICAL CABLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

K-Pack II Needle-21G x 2

FDA 510(k)

FDA Class 2 ·General Hospital

NEOLUS NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

K-PACK SURSHIELD NEEDLE, HYPODERMIC NEEDLE FOR SINGLE USE

FDA 510(k)

FDA Class 2 ·General Hospital

AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

K-PACK II NEEDLE - 29G THIN WALL

FDA 510(k)

FDA Class 2 ·General Hospital

K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall

FDA 510(k)

FDA Class 2 ·General Hospital

ADDITIONS TO WSL NITROSPRAY CRYOSURGICAL UNITS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K

FDA 510(k)

FDA Class 2 ·General Hospital

K-Pack II Needle - 29G x 5/16 Thin Wall

FDA 510(k)

FDA Class 2 ·General Hospital

SURFLO WINGED INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

AIRZONE PEAK FLOWMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology