510(k) K990213— HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET

Substantially Equivalent

Gyrus Ent LLC

Clearance details

Applicant: Gyrus Ent LLC
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 1999-01-22
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Bartlett, TN, US

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.