510(k) K081459 ยท LFL Instrument, Ultrasonic Surgical
CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM
| Applicant | Integra Radionics, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Aug 13, 2008 |
| Received | May 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081459
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2014 | Integra LifeSciences Corp. Integra Selector Kit
Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation Terminated |
LFL | None listed |
| Jun 17, 2011 | Integra Limited Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module
The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and Terminated |
LFL | None listed |
| Sep 30, 2010 | Integra LifeSciences Corp. Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System
CUSANXT1:Latex Free, Rx only:
Integra LifeSciences (Ireland) Limited,
County Offaly, Ireland;
Distributed by Integra Life Sciences Corporat Terminated |
LFL | None listed |
| Sep 30, 2010 | Integra LifeSciences Corp. Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System
CUSANXT2: Latex Free, Rx only.
Integra LifeSciences (Ireland) Limited
County Offaly, Ireland
Distributed by Integra Lifesciences Corporatio Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.