510(k) K053318 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
RX EPIDURAL NEEDLE
| Applicant | Epimed International, Inc., Johnstown NY, US |
| Decision | Substantially Equivalent, Feb 17, 2006 |
| Received | Nov 30, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2017 | Epimed International RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter Terminated |
OGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.