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

Substantially Equivalent

Gyrus Ent LLC

FDA 510(k) clearance K990213 for HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET, Substantially Equivalent on 1999-02-02. Applicant: 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

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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.