Cleared Traditional

K110792 - GELPOINT PATH
(FDA 510(k) Clearance)

K110792 · Applied Medical Resources Corp. · Gastroenterology & Urology

May 2011

Decision

63d

Days

Class 2

Risk

K110792 is an FDA 510(k) clearance for the GELPOINT PATH, a Anoscope And Accessories (Class II — Special Controls, product code FER), submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on May 23, 2011, 63 days after receiving the submission on March 21, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K110792 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2011
Decision Date	May 23, 2011
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	FER — Anoscope And Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Examine And Perform Procedures Within The Anus And Rectum.