Cleared Special

THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES

K103647 · Thd Spa · Gastroenterology & Urology

Mar 2011

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K103647 is an FDA 510(k) clearance for the THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES, a Anoscope And Accessories (Class II — Special Controls, product code FER), submitted by Thd Spa (Imoa, IT). The FDA issued a Cleared decision on March 1, 2011, 78 days after receiving the submission on December 13, 2010. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K103647 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2010
Decision Date	March 01, 2011
Days to Decision	78 days
Submission Type	Special
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.