GRIESHABER VISCOELASTIC INJECTION SYSTEM— 510(k) K890783

Substantially Equivalent

Grieshaber & Co.

FDA 510(k) clearance K890783 for GRIESHABER VISCOELASTIC INJECTION SYSTEM, Substantially Equivalent on 1989-05-16. Applicant: Grieshaber & Co..

Clearance details

Applicant: Grieshaber & Co.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 1989-02-15
Decision date: 1989-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Langhorne, PA, US

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.