Cleared Special

K100345 - SYSTEMS INTEGRATION MODEL: ENDOALPHA

K100345 is the FDA 510(k) clearance for SYSTEMS INTEGRATION MODEL: ENDOALPHA by Olympus Medical Systems Corporation. It is a Class 2 Gastroenterology & Urology device (product code ODA) cleared through the Special 510(k) pathway after a 45-day FDA review.

K100345 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
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Mar 2010
Decision
45d
Days
Class 2
Risk

K100345 is an FDA 510(k) clearance for the SYSTEMS INTEGRATION MODEL: ENDOALPHA. Classified as Endoscopic Central Control Unit (product code ODA), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on March 22, 2010 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K100345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2010
Decision Date March 22, 2010
Days to Decision 45 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 130d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODA Endoscopic Central Control Unit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Control Endoscopic And Other Ancillary Surgical Equipment In One Central Location, Either By Remote Control, Touch Screen, Or Voice Command.
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 - ODA Endoscopic Central Control Unit

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