Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker
FDA 510(k) K130537 · Biopsy Sciences, LLC
510(k) numberK130537
Submission
- Device name
- Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker
- Applicant
- Biopsy Sciences, LLC
Yorba Linda, CA, US - Received
- March 1, 2013
- Decision date
- March 29, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K121113 | Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerNEU · Traditional | 07/12/2012SE |
| K090501 | Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…NEU · Special | 03/05/2009SE |
| K083006 | Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerNEU · Special | 02/09/2009SE |
| K060769 | Hydromark Biopsy Site MarkerNEU · Traditional | 07/25/2006SE |
| K041331 | Biopsy Sciences, LLC, Lung Biopsy Site MarkerGDW · Traditional | 06/15/2004SE |
| K023694 | Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site MarkerNEU · Traditional | 03/17/2003SE |
| K021847 | Biopsy Sciences, LLC Maxi-Cell Biopsy NeedlesFCG · Traditional | 09/03/2002SE |
Questions and answers
When was Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker cleared by the FDA?
Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker (K130537) received a 510(k) decision of Substantially Equivalent on March 29, 2013, 28 days after the submission was received.
What is the product code of K130537?
The FDA product code is NEU – Marker, Radiographic, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4300.