POLYTUBE— 510(k) K982306

Substantially Equivalent

Ferris Mfg. Corp.

FDA 510(k) clearance K982306 for POLYTUBE, Substantially Equivalent on 1998-09-22. Applicant: Ferris Mfg. Corp..

Clearance details

Applicant: Ferris Mfg. Corp.
Product code: Code MGQ
Advisory panel: Unknown
Date received: 1998-07-01
Decision date: 1998-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burr Ridge, IL, US

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Adverse events under product code MGQ

product code MGQ

Death: 16
Total: 16

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.