Cleared Special

FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES

K091490 · Thd Spa · Gastroenterology & Urology

Jun 2009

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K091490 is an FDA 510(k) clearance for the FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/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 June 11, 2009, 22 days after receiving the submission on May 20, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K091490 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 20, 2009
Decision Date	June 11, 2009
Days to Decision	22 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.