Cleared Traditional

BONE BIOPSY NEEDLE

K001132 · Promex, Inc. · Gastroenterology & Urology
May 2000
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K001132 is an FDA 510(k) clearance for the BONE BIOPSY NEEDLE, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Promex, Inc. (Franklin, US). The FDA issued a Cleared decision on May 1, 2000, 21 days after receiving the submission on April 10, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K001132 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2000
Decision Date May 01, 2000
Days to Decision 21 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

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

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