The following data is part of a premarket notification filed by Devicor Medical Products, Inc. with the FDA for Mammotome Elite Biopsy System-13g Probe, Mammotome Elite Biopsy System-10g Probe, Mammotome Elite Biopsy System-holster, Mammotome Elite Biopsy System-13g Introducer Stylet, Mammotome Elite Biopsy System-10g Introducer Stylet.
| Device ID | K153709 |
| 510k Number | K153709 |
| Device Name: | Mammotome Elite Biopsy System-13G Probe, Mammotome Elite Biopsy System-10G Probe, Mammotome Elite Biopsy System-Holster, Mammotome Elite Biopsy System-13G Introducer Stylet, Mammotome Elite Biopsy System-10G Introducer Stylet |
| Classification | Instrument, Biopsy |
| Applicant | DEVICOR MEDICAL PRODUCTS, INC. 300 E-BUSINESS WAY, FIFTH FLOOR Cincinnati, OH 45241 |
| Contact | Shawna Rose |
| Correspondent | Shawna 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 | 2015-12-23 |
| Decision Date | 2016-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841911100895 | K153709 | 000 |
| 10841911100888 | K153709 | 000 |
| 00841911100850 | K153709 | 000 |
| 10841911100871 | K153709 | 000 |
| 10841911100864 | K153709 | 000 |
| 00841911101703 | K153709 | 000 |
| 00841911102823 | K153709 | 000 |
| 10841911102806 | K153709 | 000 |
| 10841911102790 | K153709 | 000 |