510(k) K813338 ยท FSH Tray, Surgical, Needle
BIOPSY NEEDLES & TRAYS
| Applicant | American Pharmaseal Div. Ahsc, Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 28, 1982 |
| Received | Nov 24, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813338
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Bard Access Systems, Inc. 4380 ECONOMY SOFT TISSUE BIOPSY TRAY
UDI-DI Code: 0110885403108563
4382A SOFT TISSUE BIOPSY TRAY
UDI-DI Code: 0110885403108501
The Soft Tissue Biopsy devices are indicated for use in the collection Open, Classified |
FSH | None listed |
| Feb 23, 2017 | Carefusion 2200 Inc JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE; Terminated |
FSH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.