Cleared Traditional

PROSTATIC CORE-CUT NEEDLE

K883884 · Euro-Med Intl. · Gastroenterology & Urology
Dec 1988
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K883884 is an FDA 510(k) clearance for the PROSTATIC CORE-CUT NEEDLE, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Euro-Med Intl. (Marlborough, US). The FDA issued a Cleared decision on December 5, 1988, 83 days after receiving the submission on September 13, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K883884 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 1988
Decision Date December 05, 1988
Days to Decision 83 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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