510(k) K001096 ยท GXR Cover, Burr Hole
BURR HOLE COVER, MODEL XX
| Applicant | Image-Guided Neurologics, Inc., Melbourne FL, US |
| Decision | Substantially Equivalent, Oct 25, 2000 |
| Received | Apr 4, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001096
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 2, 2021 | Medtronic Neuromodulation Medtronic StimLoc Burr Hole Cover, Part Numbers:
a) 3387S-40
b) 3389S-28
c) 3389S-40
d) 3391S-40
e) 3550S-01
f) 924256
g) DB-5000 Open, Classified |
GXR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.