Cleared Special

BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT

K133948 · Bard Peripheral Vascular, Inc. · Gastroenterology & Urology
Feb 2014
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K133948 is an FDA 510(k) clearance for the BARD(R) MONOPTY(R) DISPOSABLE CORE BIOPSY INSTRUMENT, BARD(R) MAX-CORE(R) DISPOSABLE CORE INSTRUMENT, 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 February 21, 2014, 60 days after receiving the submission on December 23, 2013. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K133948 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2013
Decision Date February 21, 2014
Days to Decision 60 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
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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