Cleared Special

K022169 - CLEARVIEW PLUS BONE AND VERTEBRAL BODY ...

K022169 is an FDA 510(k) clearance for CLEARVIEW PLUS BONE AND VERTEBRAL BODY ..., manufactured by Parallax Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Special 510(k) pathway after a 22-day FDA review.

K022169 · Parallax Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
22d
Days
Class 2
Risk

K022169 is an FDA 510(k) clearance for the CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Parallax Medical, Inc. (Scotts Valley, US). The FDA issued a Cleared decision on July 25, 2002 after a review of 22 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 Parallax Medical, Inc. devices

FDA 510(k) Submission Details - K022169

510(k) Number K022169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2002
Decision Date July 25, 2002
Days to Decision 22 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
108d faster than avg
Panel avg: 130d · This submission: 22d
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 K022169.
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