Cleared Traditional

K940156 - THE REEL THING

K940156 is an FDA 510(k) clearance for THE REEL THING, manufactured by Bio-Medical Devices, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 146-day FDA review.

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

K940156 is an FDA 510(k) clearance for the THE REEL THING. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Bio-Medical Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on June 7, 1994 after a review of 146 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Medical Devices, Inc. devices

FDA 510(k) Submission Details - K940156

510(k) Number K940156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 115d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GBX Catheter, Irrigation

All 46
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