HYDRACLEAR PUMP CONSOLE, HYDRACLEAR POWER SUPPLLY, HYDRACLEAR FOOTSWITCH, HYDRACLEAR SHEATHS, HYDRACLEAR SET— 510(k) K990213
Substantially EquivalentGyrus 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. Device class: 2.
Clearance details
- Applicant
- Gyrus Ent LLC
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- 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, through . 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.