Biopsy Needle Guide Kit
Regulation 892.1560
0510(k)s in 12 months (0 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in OIJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Devicor Medical Products Inc | 0 | 1 |
| Hologic, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2017 | Hologic, Inc. Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880 Terminated |
OIJ | K161575 |
| Jul 14, 2016 | Devicor Medical Products Inc Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graph Terminated |
OIJ | K123259 |
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