The following data is part of a premarket notification filed by Devicor Medical Products, Inc. with the FDA for Mammotome Revolve Dual Vacuum Assist Biopsy System.
| Device ID | K152989 |
| 510k Number | K152989 |
| Device Name: | Mammotome Revolve Dual Vacuum Assist Biopsy System |
| Classification | Instrument, Biopsy |
| Applicant | DEVICOR MEDICAL PRODUCTS, INC. 300 E-BUSINESS WAY, FIFTH FLOOR Cincinnati, OH 45241 |
| Contact | Shawna M. Rose |
| Correspondent | Shawna M. Rose DEVICOR MEDICAL PRODUCTS, INC. 300 E-BUSINESS WAY, FIFTH FLOOR Cincinnati, OH 45241 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-13 |
| Decision Date | 2016-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911100826 | K152989 | 000 |
| 10841911102592 | K152989 | 000 |
| 10841911102585 | K152989 | 000 |
| 10841911102578 | K152989 | 000 |
| 10841911102561 | K152989 | 000 |
| 00841911102267 | K152989 | 000 |
| 00841911102045 | K152989 | 000 |
| 00841911101895 | K152989 | 000 |
| 00841911101871 | K152989 | 000 |
| 00841911101864 | K152989 | 000 |
| 00841911102328 | K152989 | 000 |
| 10841911102721 | K152989 | 000 |
| 10841911102714 | K152989 | 000 |
| 10841911102707 | K152989 | 000 |
| 10841911102608 | K152989 | 000 |
| 10841911102615 | K152989 | 000 |
| 10841911100819 | K152989 | 000 |
| 10841911100765 | K152989 | 000 |
| 10841911100758 | K152989 | 000 |
| 10841911100741 | K152989 | 000 |
| 10841911100734 | K152989 | 000 |
| 10841911100727 | K152989 | 000 |
| 10841911100710 | K152989 | 000 |
| 00841911100706 | K152989 | 000 |
| 00841911100690 | K152989 | 000 |
| 00841911100683 | K152989 | 000 |
| 00841911100676 | K152989 | 000 |
| 00841911100669 | K152989 | 000 |
| 00841911100652 | K152989 | 000 |
| 00841911102694 | K152989 | 000 |