Cleared Special

EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G

K192948 · Bard Peripheral Vascular, Inc. · General & Plastic Surgery
Nov 2019
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K192948 is an FDA 510(k) clearance for the EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on November 7, 2019, 20 days after receiving the submission on October 18, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K192948 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KNW — Instrument, Biopsy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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