510(k) K974814 ยท KNW Instrument, Biopsy
MANAN(TM) SUPER-CORE BIOPSY NEEDLES
| Applicant | Medical Device Technologies, Inc., Gainsville FL, US |
| Decision | Substantially Equivalent, Jan 9, 1998 |
| Received | Dec 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974814
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2021 | Argon Medical Devices, Inc SuperCore Biopsy Instrument:
REF/Product Description:
701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM;
701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM;
701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM;
701118060 Open, Classified |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.