HydroMARK Plus Breast Biopsy Site Marker— 510(k) K221961
Substantially EquivalentDevicor Medical Products, Inc.
FDA 510(k) clearance K221961 for HydroMARK Plus Breast Biopsy Site Marker, Substantially Equivalent on 2023-07-13. Applicant: Devicor Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Devicor Medical Products, Inc.
- Product code
- Code NEU
- Device class
- Class 2
- Regulation
- 21 CFR 878.4300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code NEU
view allMore clearances from Devicor Medical Products, Inc.
view all- K260365 — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module +5 more
- K243095 — Mammotome AutoCore Single Insertion Core Biopsy System
- K240527 — HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
- K232615 — LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)) +2 more
- K212158 — HydroMARK Breast Biopsy Site Marker
Adverse events under product code NEU
product code NEU- Injury
- 824
- Total
- 824
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.