510(k) K152339 ยท FMI Needle, Hypodermic, Single Lumen
Unifine Pentips/ Unifine Pentips Plus
| Applicant | Owen Mumford, Ltd., Woodstock, GB |
| Decision | Substantially Equivalent, Jun 24, 2016 |
| Received | Aug 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152339
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2021 | Owen Mumford USA, Inc. Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover. Open, Classified |
FMI | None listed |
| Nov 6, 2017 | Owen Mumford USA, Inc. Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles.
Product Usage:
Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen inject Terminated |
FMI | None listed |
| Nov 6, 2017 | Owen Mumford USA, Inc. Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles.
Product Usage:
Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen inject Terminated |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.