Cleared Traditional

INSTRUMENT DAMPING PORT

K011373 · Medcanica, Inc. · Cardiovascular
Oct 2001
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K011373 is an FDA 510(k) clearance for the INSTRUMENT DAMPING PORT, a Trocar (Class II — Special Controls, product code DRC), submitted by Medcanica, Inc. (Miami, US). The FDA issued a Cleared decision on October 12, 2001, 161 days after receiving the submission on May 4, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1390.

Submission Details

510(k) Number K011373 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2001
Decision Date October 12, 2001
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRC — Trocar
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1390

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