Cleared Traditional

MULTIPLE BIOPSY DEVICE-MBX

K911448 · Triton Technology, Inc. · Gastroenterology & Urology
Apr 1991
Decision
32d
Days
Class 2
Risk

About This 510(k) Submission

K911448 is an FDA 510(k) clearance for the MULTIPLE BIOPSY DEVICE-MBX, a Instrument, Biopsy, Suction (Class II — Special Controls, product code FCK), submitted by Triton Technology, Inc. (Salem, US). The FDA issued a Cleared decision on April 16, 1991, 32 days after receiving the submission on March 15, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K911448 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1991
Decision Date April 16, 1991
Days to Decision 32 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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