510(k) K982401 ยท KNW Instrument, Biopsy
PROSTATE BIOPSY NEEDLE
| Applicant | Remington Medical, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Sep 8, 1998 |
| Received | Jul 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982401
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2012 | Remington Medical Inc. Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005.
Prostate Biopsy Needles shall be single use only and a Terminated |
KNW | None listed |
| Mar 29, 2007 | Remington Medical Inc. Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005. Terminated |
KNW | None listed |
| Apr 8, 2005 | Remington Medical Inc. Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005. Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.