G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES)— 510(k) K954041

Substantially Equivalent

Glaxo, Inc.

FDA 510(k) clearance K954041 for G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES), Substantially Equivalent on 1995-10-16. Applicant: Glaxo, Inc..

Clearance details

Applicant: Glaxo, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 1995-08-29
Decision date: 1995-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Research Triangle Park, NC, US

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.