Cleared Special

K112945 - ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K112945 · Inrad, Inc. · Gastroenterology & Urology device
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Nov 2011
Decision
30d
Days
Class 2
Risk

K112945 is an FDA 510(k) clearance for the ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIE.... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Inrad, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on November 3, 2011 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - 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 Inrad, Inc. devices

Submission Details

510(k) Number K112945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2011
Decision Date November 03, 2011
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
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 - KNW Instrument, Biopsy

All 359
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