510(k) K072005 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
RK EPIDURAL NEEDLE
| Applicant | Epimed International, Johnston NY, US |
| Decision | Substantially Equivalent, Feb 7, 2008 |
| Received | Jul 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072005
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2016 | Epimed International, Inc. 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415
Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia Terminated |
BSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.