OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT)— 510(k) K962485

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K962485 for OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT), Substantially Equivalent on 1996-08-20. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 1996-06-26
Decision date: 1996-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

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.