K881697 is an FDA 510(k) clearance for the BREAST LESION LOCALIZATION NEEDLE. This device is classified as a System, X-ray, Mammographic (Class II - Special Controls, product code IZH).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 14, 1988, 148 days after receiving the submission on April 19, 1988.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1710.
| 510(k) Number | K881697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1988 |
| Decision Date | September 14, 1988 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IZH — System, X-ray, Mammographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1710 |