510(k) K854816 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
EPIDURAL ANESTHESIA NEEDLES
| Applicant | Reganes, Inc., Clearwater FL, US |
| Decision | Substantially Equivalent, Dec 19, 1985 |
| Received | Dec 3, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854816
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2015 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra Long Epidural Steroid Injection Needle (Catalogue #PITRW2050) Terminated |
BSP | None listed |
| Apr 29, 2015 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal Stylet, Calibrations (10BX), Catalogue No. PITRW1850.
Used to administer steroid medication in t Terminated |
BSP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.