Cleared Special

FX WIRE ADVANCED MEASUREMENT GUIDEWIRE

K050304 · Conmedcorp · Gastroenterology & Urology

Mar 2005

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K050304 is an FDA 510(k) clearance for the FX WIRE ADVANCED MEASUREMENT GUIDEWIRE, a Endoscopic Guidewire, Gastroenterology-urology (Class II — Special Controls, product code OCY), submitted by Conmedcorp (Billerica, US). The FDA issued a Cleared decision on March 8, 2005, 28 days after receiving the submission on February 8, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K050304 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2005
Decision Date	March 08, 2005
Days to Decision	28 days
Submission Type	Special
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.