Cleared Traditional

THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE

K121135 · Thd Spa · Gastroenterology & Urology

Jun 2012

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K121135 is an FDA 510(k) clearance for the THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE, a Anoscope And Accessories (Class II — Special Controls, product code FER), submitted by Thd Spa (Imoa, IT). The FDA issued a Cleared decision on June 1, 2012, 49 days after receiving the submission on April 13, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K121135 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 2012
Decision Date	June 01, 2012
Days to Decision	49 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.