Cleared Traditional

VR MEDICAL ENTERAL ORAL SYRINGE

K110853 · Vr Medical · Gastroenterology & Urology

May 2011

Decision

46d

Days

Class 2

Risk

About This 510(k) Submission

K110853 is an FDA 510(k) clearance for the VR MEDICAL ENTERAL ORAL SYRINGE, a Tube, Feeding (Class II — Special Controls, product code FPD), submitted by Vr Medical (Zhouzhuang, CN). The FDA issued a Cleared decision on May 13, 2011, 46 days after receiving the submission on March 28, 2011. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K110853 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2011
Decision Date	May 13, 2011
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF