HydroMARK Breast Biopsy Site Marker
FDA 510(k) K212158 · Devicor Medical Products, Inc.
510(k) numberK212158
Submission
- Device name
- HydroMARK Breast Biopsy Site Marker
- Applicant
- Devicor Medical Products, Inc.
Cincinnati, OH, US - Received
- July 12, 2021
- Decision date
- April 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NEU – Marker, Radiographic, Implantable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Other 510(k)s with product code NEU
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast…NEU · Traditional | Devicor Medical Products, Inc. | 01/23/2026SE |
| K253888 | MOLLI 2 SystemNEU · Special | Stryker Endoscopy | 12/31/2025SE |
| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | Merit Medical Systems, Inc. | 12/19/2025SE |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001)NEU · Traditional | Breast-Med, Inc. | 12/12/2025SE |
| K251748 | MammoSTAR Biopsy Site IdentifierNEU · Traditional | Carbon Medical Technologies, Inc. | 07/23/2025SE |
| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | Bard Peripheral Vascular, Inc. | 03/24/2025SE |
| K233639 | SmartClip Secure Soft Tissue MarkerNEU · Traditional | Elucent Medical, Inc. | 12/20/2024SE |
| K240429 | Trilogy Tissue MarkerNEU · Traditional | Inrad, Inc. | 11/07/2024SE |
| K234149 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/26/2024SE |
| K240042 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/25/2024SE |
More from Molli Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional | 03/04/2026SE |
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast…NEU · Traditional | 01/23/2026SE |
| K243095 | Mammotome AutoCore Single Insertion Core Biopsy SystemKNW · Traditional | 10/29/2024SE |
| K240527 | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)NEU · Traditional | 07/10/2024SE |
| K232615 | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker…NEU · Traditional | 01/12/2024SE |
| K221961 | HydroMARK Plus Breast Biopsy Site MarkerNEU · Traditional | 07/13/2023SE |
| K210752 | HydroMARK Breast Biopsy Site MarkerNEU · Special | 04/14/2021SE |
| K203097 | HydroMARK Breast Biopsy Site MarkersNEU · Traditional | 12/16/2020SE |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) SystemKNW · Traditional | 08/18/2020SE |
| K170803 | HydroMARK Breast Biopsy Site MarkersNEU · Traditional | 06/15/2017SE |
Questions and answers
When was HydroMARK Breast Biopsy Site Marker cleared by the FDA?
HydroMARK Breast Biopsy Site Marker (K212158) received a 510(k) decision of Substantially Equivalent on April 21, 2022, 283 days after the submission was received.
What is the product code of K212158?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.