Cleared Traditional

MAXX 470 CORE BIOPSY GUN

K900082 · Dlp, Inc. · Gastroenterology & Urology
Jun 1990
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K900082 is an FDA 510(k) clearance for the MAXX 470 CORE BIOPSY GUN, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on June 27, 1990, 173 days after receiving the submission on January 5, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K900082 FDA.gov
FDA Decision Cleared SESE
Date Received January 05, 1990
Decision Date June 27, 1990
Days to Decision 173 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

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

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