SPECIAL PROCEDURES BASE UNIT MODEL 500— 510(k) K881713

Substantially Equivalent

Gempco, Inc.

FDA 510(k) clearance K881713 for SPECIAL PROCEDURES BASE UNIT MODEL 500, Substantially Equivalent on 1988-07-12. Applicant: Gempco, Inc..

Clearance details

Applicant: Gempco, Inc.
Product code: Code FMT
Advisory panel: General Hospital
Date received: 1988-04-21
Decision date: 1988-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lisle, IL, US

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Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.