Cleared Special

K022879 - MODIFICATION TO SANARUS CENTRICA CORE T...

K022879 is an FDA 510(k) clearance for MODIFICATION TO SANARUS CENTRICA CORE T..., manufactured by Sanarus Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Special 510(k) pathway after a 24-day FDA review.

K022879 · Sanarus Medical, Inc. · Gastroenterology & Urology device
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Sep 2002
Decision
24d
Days
Class 2
Risk

K022879 is an FDA 510(k) clearance for the MODIFICATION TO SANARUS CENTRICA CORE TISSUE BIOPSY. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Sanarus Medical, Inc. (Pleasanton, US). The FDA issued a Cleared decision on September 23, 2002 after a review of 24 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 Sanarus Medical, Inc. devices

FDA 510(k) Submission Details - K022879

510(k) Number K022879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2002
Decision Date September 23, 2002
Days to Decision 24 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
106d faster than avg
Panel avg: 130d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

KNW Device Classification - Class 2, Special Controls

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 174
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K022879.
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