510(k) K813462 ยท KNW Instrument, Biopsy
MADAYAG TYPE NEEDLE
| Applicant | Ocean Medical Products, Ltd., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 1, 1982 |
| Received | Dec 11, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813462
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2004 | Boston Scientific Corporation Manual Biopsy Devices containing AIM system: Chiba Needle, 6 inch/15 cm, 22 gauge, Catalog #40-102, Material #M001401021 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Stre Terminated |
KNW | None listed |
| Sep 14, 2004 | Boston Scientific Corporation Manual Biopsy Devices containing AIM system: Chiba Needle, 8 inch/20 cm, 22 gauge, Cat. #40-103, Material #M001401031 (10 per box). Firm on label: Boston Scientific / MEDI-TECH, 480 Pleasant Street Terminated |
KNW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.