510(k) K120691 ยท GZT Retractor, Self-Retaining, For Neurosurgery
BRAIN PORT
| Applicant | Nico Corporation, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 5, 2012 |
| Received | Mar 7, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120691
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2012 | Nico Corp. 13.5 mm x 50 mm BrainPath Sheath
The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sh Terminated |
GZT | None listed |
| Aug 13, 2012 | Nico Corp. 13.5 mm x 60 mm BrainPath Sheath
The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sh Terminated |
GZT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.