THE REEL THING— 510(k) K940156

Name: FDA 510(k) clearance K940156
Creator: U.S. Food and Drug Administration
Published: 1994-06-07

Substantially Equivalent

Bio-Medical Devices, Inc.

FDA 510(k) clearance K940156 for THE REEL THING, Substantially Equivalent on 1994-06-07. Applicant: Bio-Medical Devices, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Medical Devices, Inc.
Product code: Code GBX
Device class: Class 1
Regulation: 21 CFR 878.4200
Advisory panel: General, Plastic Surgery
Date received: 1994-01-12
Decision date: 1994-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.