Cleared Special

ACMI VISTA CTR BIPOLAR LOOP ELECTRODE

K031001 · Acmi Corporation · Gastroenterology & Urology
May 2003
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K031001 is an FDA 510(k) clearance for the ACMI VISTA CTR BIPOLAR LOOP ELECTRODE, a Electrode, Electrosurgical, Active, Urological (Class II — Special Controls, product code FAS), submitted by Acmi Corporation (Southborough, US). The FDA issued a Cleared decision on May 21, 2003, 51 days after receiving the submission on March 31, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K031001 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2003
Decision Date May 21, 2003
Days to Decision 51 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FAS — Electrode, Electrosurgical, Active, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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