Cleared Traditional

ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC

K131072 · Coloplast A/S · Gastroenterology & Urology

Jul 2013

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K131072 is an FDA 510(k) clearance for the ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILIC, a Endoscopic Guidewire, Gastroenterology-urology (Class II — Special Controls, product code OCY), submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on July 9, 2013, 83 days after receiving the submission on April 17, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K131072 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2013
Decision Date	July 09, 2013
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	OCY — Endoscopic Guidewire, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Provide Access To Gi Or Gu Tract For The Purpose Of Passing Or Exchanging Other Accessories.