510(k) K080603 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
HYBRID NERVE LOCATION NEEDLE COATED AND UNCOATED
| Applicant | Te ME NA Sas, Appollo Beach FL, US |
| Decision | Substantially Equivalent, Aug 5, 2008 |
| Received | Mar 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080603
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2014 | RM Temena GmbH Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance. Terminated |
BSP | None listed |
| May 12, 2014 | RM Temena GmbH Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance Terminated |
BSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.