Cleared Special

K192948 - EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G (FDA 510(k) Clearance)

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

K192948 · Bard Peripheral Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
20d
Days
Class 2
Risk

K192948 is an FDA 510(k) clearance for the EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVatio.... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on November 7, 2019 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1075 - the FDA general and plastic surgery 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 Bard Peripheral Vascular, Inc. devices

Submission Details

510(k) Number K192948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2019
Decision Date November 07, 2019
Days to Decision 20 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 114d · This submission: 20d
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 359
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K192948.
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