510(k) K130136 ยท GXZ Electrode, Needle
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
| Applicant | Technomed Europe, Maastricht-Airport, NL |
| Decision | Substantially Equivalent, Jul 19, 2013 |
| Received | Jan 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130136
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2022 | Technomed Europe Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile. Terminated |
IKT | None listed |
| Dec 8, 2021 | Technomed Europe Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001. Terminated |
GXZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.