FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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
K Number: K260365
·
Decision Mar 4, 2026
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
16
Review Days
28
Basic Information
- 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
- K Number
- K260365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Devicor Medical Products, Inc.
- Date Received
- February 4, 2026
- Decision Date
- March 4, 2026
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Devicor Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) | Jan 23, 2026 | Substantially Equivalent |
| K243095 | Mammotome AutoCore Single Insertion Core Biopsy System | Oct 29, 2024 | Substantially Equivalent |
| K240527 | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | Jul 10, 2024 | Substantially Equivalent |
| K232615 | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK Biopsy Site Marker (LM0215R (Rose shape)) | Jan 12, 2024 | Substantially Equivalent |
| K221961 | HydroMARK Plus Breast Biopsy Site Marker | Jul 13, 2023 | Substantially Equivalent |
| K212158 | HydroMARK Breast Biopsy Site Marker | Apr 21, 2022 | Substantially Equivalent |
| K210752 | HydroMARK Breast Biopsy Site Marker | Apr 14, 2021 | Substantially Equivalent |
| K203097 | HydroMARK Breast Biopsy Site Markers | Dec 16, 2020 | Substantially Equivalent |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | Aug 18, 2020 | Substantially Equivalent |
| K170803 | HydroMARK Breast Biopsy Site Markers | Jun 15, 2017 | Substantially Equivalent |