SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
FDA 510(k) clearance K010309 · decided 2001-04-18
Clearance details
- K-number
- K010309
- Device name
- SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
- Applicant
- Mutoh America Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-01
- Decision date
- 2001-04-18
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech. recall (Z-2156-2014) | Stryker Instruments Div. of Stryker Corporation | 2014-08-07 |
| Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The S recall (Z-1878-2013) | Stryker Instruments Div. of Stryker Corporation | 2013-08-06 |
| Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet recall (Z-1879-2013) | Stryker Instruments Div. of Stryker Corporation | 2013-08-06 |
| Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonope recall (Z-1880-2013) | Stryker Instruments Div. of Stryker Corporation | 2013-08-06 |