Cleared Traditional

CORE BIOPSY NEEDLE, CATALOG CODE #54006

K891537 · Dlp, Inc. · General & Plastic Surgery
Apr 1989
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K891537 is an FDA 510(k) clearance for the CORE BIOPSY NEEDLE, CATALOG CODE #54006, a Needle, Aspiration And Injection, Reusable (Class I — General Controls, product code GDM), submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on April 18, 1989, 32 days after receiving the submission on March 17, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K891537 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1989
Decision Date April 18, 1989
Days to Decision 32 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GDM — Needle, Aspiration And Injection, Reusable
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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