Cleared Traditional

THE REEL THING

K940156 · Bio-Medical Devices, Inc. · General & Plastic Surgery
Jun 1994
Decision
146d
Days
Class 1
Risk

About This 510(k) Submission

K940156 is an FDA 510(k) clearance for the THE REEL THING, a Catheter, Irrigation (Class I — General Controls, product code GBX), submitted by Bio-Medical Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on June 7, 1994, 146 days after receiving the submission on January 12, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4200.

Submission Details

510(k) Number K940156 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1994
Decision Date June 07, 1994
Days to Decision 146 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code GBX — Catheter, Irrigation
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4200

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