OLYMPUS FG-45/46-1 GRASPING FORCEPS— 510(k) K955049

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K955049 for OLYMPUS FG-45/46-1 GRASPING FORCEPS, Substantially Equivalent on 1995-12-15. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1995-11-06
Decision date: 1995-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

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.