Cleared Traditional

SAPIMED DISPOSABLE SIGMOIDOSCOPE (K070915) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K070915 · Sapimed S.P.A. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
95d
Days
Class 2
Risk

K070915 is an FDA 510(k) clearance for the SAPIMED DISPOSABLE SIGMOIDOSCOPE. Classified as Sigmoidoscope, Rigid, Non-electrical (product code KDM), Class II - Special Controls.

Submitted by Sapimed S.P.A. (Crofton, US). The FDA issued a Cleared decision on July 6, 2007 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sapimed S.P.A. devices

Submission Details

510(k) Number K070915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 130d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDM Sigmoidoscope, Rigid, Non-electrical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.