510(k) K981262 ยท LFL Instrument, Ultrasonic Surgical
CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM
| Applicant | Valleylab, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Jul 6, 1998 |
| Received | Apr 7, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981262
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2014 | Integra LifeSciences Corp. Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wr Terminated |
LFL | None listed |
| Mar 8, 2013 | Integra LifeSciences Corp. Integra CUSA excel. CEM Nosecone for CUSA EXcel System.
The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX El Terminated |
LBK | None listed |
| Mar 15, 2012 | Integra LifeSciences Corp Integra CUSA EXcel Sterile Tips Rx Only
Single Use Only
Product Usage: For usage in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is des Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.