An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle
| Company | Devices | Share |
|---|---|---|
| Hologic, Inc. | 70 | 44% |
| Devicor Medical Products, Inc. | 52 | 33% |
| Senorx, Inc. | 14 | 9% |
| Manus Medical, Llc | 7 | 4% |
| Bard Peripheral Vascular, Inc. | 7 | 4% |
| Manan Medical Products, Inc. | 4 | 3% |
| Medicalpark Co.,Ltd. | 2 | 1% |
| I.M.S. Internazionale Medico Scientifica Srl | 2 | 1% |
| Ims Giotto Spa | 1 | 1% |
Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| KNW | Instrument, Biopsy | 58 |
| KNW | INSTRUMENT, BIOPSY | 46 |
| IZH | System, x-ray, mammographic | 29 |
| PXP | Breast biopsy / localization tray | 24 |
| LRO | General Surgery Tray | 6 |
| KNW | Instrument, biopsy | 5 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
159 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mammographic stereotactic biopsy system", from 9 companies. The largest labeler is Hologic, Inc. with 44% of records.
KNW (Instrument, Biopsy), KNW (INSTRUMENT, BIOPSY), IZH (System, x-ray, mammographic), PXP (Breast biopsy / localization tray)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.