Cleared Traditional

Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff

K150927 · Coloplast A/S · Gastroenterology & Urology

May 2015

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K150927 is an FDA 510(k) clearance for the Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire straight stiff, Orchestra Hydrophilic Guidewire angled stiff,Orchestra Hydrophilic Guidewire standard straight, Orchestra Hydrophilic Guidewire straight stiff, 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 May 27, 2015, 51 days after receiving the submission on April 6, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K150927 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 2015
Decision Date	May 27, 2015
Days to Decision	51 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.