Cleared Traditional

SUCTION BIOPSY INSTRUMENT

K895420 · Mill-Rose Laboratory · Gastroenterology & Urology
Feb 1990
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K895420 is an FDA 510(k) clearance for the SUCTION BIOPSY INSTRUMENT, a Instrument, Biopsy, Suction (Class II — Special Controls, product code FCK), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on February 9, 1990, 161 days after receiving the submission on September 1, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K895420 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1989
Decision Date February 09, 1990
Days to Decision 161 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

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

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