Cleared Traditional

MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE (K083840) - FDA 510(k) Clearance

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

K083840 · Msi Medserv International Deutschland GmbH · Gastroenterology & Urology device
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Sep 2009
Decision
278d
Days
Class 2
Risk

K083840 is an FDA 510(k) clearance for the MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE. Classified as Endoscope, Rigid (product code GCM), Class II - Special Controls.

Submitted by Msi Medserv International Deutschland GmbH (Pfullendorf, DE). The FDA issued a Cleared decision on September 28, 2009 after a review of 278 days - an extended review cycle.

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 Msi Medserv International Deutschland GmbH devices

Submission Details

510(k) Number K083840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2008
Decision Date September 28, 2009
Days to Decision 278 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
148d slower than avg
Panel avg: 130d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCM Endoscope, Rigid
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.

Regulatory Peers - GCM Endoscope, Rigid

All 17
Devices cleared under the same product code (GCM) and FDA review panel - the closest regulatory comparables to K083840.
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