GRAVITY PLUS CONTROLLER/COMPOUNDER— 510(k) K902853

Substantially Equivalent

Fergy Corp.

FDA 510(k) clearance K902853 for GRAVITY PLUS CONTROLLER/COMPOUNDER, Substantially Equivalent on 1991-05-09. Applicant: Fergy Corp..

Clearance details

Applicant: Fergy Corp.
Product code: Code LHI
Advisory panel: General Hospital
Date received: 1990-06-29
Decision date: 1991-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grass Valley, CA, US

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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.