510(k) K133697
- Device
- BREAST-MED TISSUE MARKER
- Applicant
- BREAST-MED, INC.
- 510(k) number
- K133697
- Product code
- NEU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-10
- Date received
- 2013-12-03
- Regulation
- 878.4300
- Classification name
- Marker, Radiographic, Implantable
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL NELSON
- Address
- 1745 Bridgewater Rd. Golden Valley MN US 55422 55422
FDA Registration Numbers#
- 1222780
- 3011162972
- 2029275
- 3007200016
- 3006981798
- 9680340
- 1211566
- 2951215
- 3014680735
- 3021008900
- 3007055279
- 3005636544
- 1625425
- 2134494
- 3008627763
- 3018024590
- 2936485
- 3002907620
- 3018094310
- 3021179744
- 1018233
- 3008492462
- 1835568
- 3015439135
- 1928237
- 3015924373
- 3009649442
- 1064858
- 3020733550
- 1220477
- 2020394
- 1020279
- 3004111573
- 3013012623
- 1825034
- 3009039068
- 1644312
- 3007305589
- 1037905
- 3014090621
- 3011245468
- 1417485
- 3009905888
- 1222140
- 3008706707
- 3016678045
- 3015207155
- 2022435
- 9617429
- 3030733800
- 2032338
- 3013649990
- 1054811
- 3033589330
- 3008744062
- 3019807891
- 3009077524
- 3008236846
- 3013176080
- 1000393132
- 3008992312
- 3004904811
- 3035366890
- 1647149
- 3015225571
- 3006082230
- 3014967969
- 3005160949
- 3000126629
- 3009609358
- 3012644426
- 3038503932
- 3010813819
- 2183744
- 3012345110
- 3015309643
- 3006950086
- 1450662
- 3010339638
Source Documents#
Other 510(k) Records For Product Code NEU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253761 | HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) | Devicor Medical Products, Inc. | 2026-01-23 |
| K253888 | MOLLI 2 System | Stryker Endoscopy | 2025-12-31 |
| K252892 | SCOUT MD Surgical Guidance System | Merit Medical Systems, Inc. | 2025-12-19 |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001) | Breast-Med, Inc. | 2025-12-12 |
| K251748 | MammoSTAR Biopsy Site Identifier | Carbon Medical Technologies, Inc. | 2025-07-23 |
| K243642 | UltraCor™ Twirl™ Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 2025-03-24 |
| K233639 | SmartClip Secure Soft Tissue Marker | Elucent Medical, Inc. | 2024-12-20 |
| K240429 | Trilogy Tissue Marker | Inrad, Inc. | 2024-11-07 |
| K234149 | MOLLI 2 System | Molli Surgical, Inc. | 2024-09-26 |
| K240042 | MOLLI 2 System | Molli Surgical, Inc. | 2024-09-25 |
| K241762 | OneMark | View Point Medical | 2024-09-16 |
| K240527 | HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) | Devicor Medical Products, Inc. | 2024-07-10 |
| K232865 | Magseed Pro Magnetic Marker System | Endomagnetics Ltd., | 2024-06-28 |
| K231468 | SCOUT MD Surgical Guidance System | Merit Medical System, Inc. | 2024-02-12 |
| K230836 | SchurSign Tissue Marker | Surgmark GmbH | 2024-01-23 |
Legacy Summary#
summary
FDA Review#
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