Cleared Traditional

Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet

K153709 · Devicor Medical Products, Inc. · Gastroenterology & Urology
Aug 2016
Decision
229d
Days
Class 2
Risk

About This 510(k) Submission

K153709 is an FDA 510(k) clearance for the Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe, Mammotome elite Biopsy System-Holster, Mammotome elite Biopsy System-13G Introducer Stylet, Mammotome elite Biopsy System-10G Introducer Stylet, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Devicor Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on August 8, 2016, 229 days after receiving the submission on December 23, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K153709 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2015
Decision Date August 08, 2016
Days to Decision 229 days
Submission Type Traditional
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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