510(k) K010309 ยท LFL Instrument, Ultrasonic Surgical
SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
| Applicant | Mutoh America Co., Ltd., Deer Field IL, US |
| Decision | Substantially Equivalent, Apr 18, 2001 |
| Received | Feb 1, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010309
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2014 | Stryker Instruments Div. of Stryker Corporation Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech. Terminated |
LFL | None listed |
| Aug 6, 2013 | Stryker Instruments Div. of Stryker Corporation Sonopet Ultrasonic Aspirator Console
(Console 110V with Pedal & Pole)
Product Usage:
The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiratio Terminated |
LFL | None listed |
| Aug 6, 2013 | Stryker Instruments Div. of Stryker Corporation Sonopet Ultrasonic Aspirator Console
5450-851-000(Console 100V)
Product Usage:
The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of Terminated |
LFL | None listed |
| Aug 6, 2013 | Stryker Instruments Div. of Stryker Corporation Sonopet Ultrasonic Aspirator Console
5450-852-000 (Console 230V)
Product Usage:
The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.