510(k) K131072

ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC by Coloplast A/S — Product Code OCY

K131072 is an FDA 510(k) premarket notification submitted by Coloplast A/S for the device "ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC". The FDA issued a decision of Substantially Equivalent on July 9, 2013. The device falls under product code OCY (Endoscopic Guidewire, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Coloplast A/S has at least 10 other 510(k) clearances on record.