SecurMark for Atec
SecurMark for ATEC Stainless steel biopsy site marker
1manufacturer
15catalogue numbers in this listing
1510(k) clearance
3recalls on this code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Hologic, Inc., United States |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K102608 |
| Record published | 2015-08-29 |
| Record revised | 2024-05-03 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 50 °C |
| Packaging | Box of 10 |
| Distribution end date | 2017-02-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SMARK-A3609-SS1 | In distribution | |
| SMARK-ATEC-13-09 | In distribution | |
| SMARK-ATEC-36-09 | In distribution | |
| SMARK-A1312-SS2 | In distribution | |
| SMARK-ATEC-2S-13-12 | In distribution | |
| SMARK-ATEC-2S-36-09 | In distribution | |
| SMARK-ATEC-2S-13-09 | In distribution | |
| SMARK-ATEC-13-12 | In distribution | |
| SMARK-ATEC-36-12 | In distribution | |
| SMARK-A3609-SS3 | Withdrawn | |
| SMARK-ATEC-2S-36-12 | Withdrawn | |
| SMARK-A1309-SS1 | Withdrawn | |
| SMARK-A1312-SS1 | Withdrawn | |
| SMARK-A1309-SS2 | Withdrawn | |
| SMARK-A3609-SS2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HydroMARK | Devicor Medical Products, Inc. | 75 |
| Scout® | Merit Medical Systems, Inc. | 68 |
| Scout MD™ | Merit Medical Systems, Inc. | 46 |
| SmartClip | Elucent Medical Inc. | 37 |
| BiomarC® | Carbon Medical Technologies, Inc. | 25 |
| HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 21 |
| SecurMark | Hologic, Inc. | 15 |
| Gold Marker | Riverpoint Medical LLC | 15 |
| MammoStar™ | Carbon Medical Technologies, Inc. | 15 |
| SenoMark® Ultra Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 14 |
| TriMark | Hologic, Inc. | 14 |
| Mammotome revolve MammoMark | Devicor Medical Products, Inc. | 10 |
Showing 12 of 96. All products under Marker, Radiographic, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102768 | 2010-12-02 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-10-10 | Class I | Device Design | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. | 12,710 units |
| 2024-03-13 | Class I | Unknown/Undetermined by firm | Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for ad | 53492 |
| 2022-08-09 | Class II | Incorrect or no expiration date | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing da | 233 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.