HydroMARK Breast Biopsy Site Marker— 510(k) K161021

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

2016-04-12

Decision date

2016-05-05

Decision

Substantially Equivalent

Clearance type

Special

Location

Cincinnati, OH, US

• K253761 — HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)2026-01-23
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• K252892 — SCOUT MD Surgical Guidance System2025-12-19
• K251989 — VizMark Preloaded Tissue Marker Device (VM-0001)2025-12-12
• K251748 — MammoSTAR Biopsy Site Identifier2025-07-23

• K260365 — Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module +5 more2026-03-04
• K243095 — Mammotome AutoCore Single Insertion Core Biopsy System2024-10-29
• K240527 — HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)2024-07-10
• K232615 — LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)) +2 more2024-01-12
• K221961 — HydroMARK Plus Breast Biopsy Site Marker2023-07-13

Injury

824

Total

824

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →