K260365
- 510(k) number
- K260365
- Device name
- Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char
- Applicant
- Devicor Medical Products, Inc. OH · US
- Product code
- KNW — Instrument, Biopsy
- Decision date
- 2026-03-04
- Date received
- 2026-02-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K260365.pdf
Official FDA record: K260365
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.