510(k) K060973 ยท GZT Retractor, Self-Retaining, For Neurosurgery
VYCOR SURGICAL ACCESS SYSTEMS
| Applicant | Vycor Medical, LLC, Shelton CT, US |
| Decision | Substantially Equivalent, Jul 26, 2006 |
| Received | Apr 10, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060973
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2013 | Vycor Medical, Inc. Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE***
Product Usage:
The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor s Terminated |
GZT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.