Cleared Traditional

SAPIMED DISPOSABLE SIGMOIDOSCOPE

K070915 · Sapimed S.P.A. · Gastroenterology & Urology
Jul 2007
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K070915 is an FDA 510(k) clearance for the SAPIMED DISPOSABLE SIGMOIDOSCOPE, a Sigmoidoscope, Rigid, Non-electrical (Class II — Special Controls, product code KDM), submitted by Sapimed S.P.A. (Crofton, US). The FDA issued a Cleared decision on July 6, 2007, 95 days after receiving the submission on April 2, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K070915 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2007
Decision Date July 06, 2007
Days to Decision 95 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KDM — Sigmoidoscope, Rigid, Non-electrical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500