EchoMark LP
EchoMark LP is an implantable marker that makes a soft tissue site visible on ultrasound for later medical procedures. It acts as a passive imaging contrast at the marked location and is…
EchoMark LP is an implantable marker that makes a soft tissue site visible on ultrasound for later medical procedures. It acts as a passive imaging contrast at the marked location and is the smaller, low profile member of the EchoMark marker family.
The marker is made entirely from a bioresorbable polymer, 70:30 poly(L-lactide-co-caprolactone). The material resorbs completely over one year or longer. The device is supplied sterile and is intended for a single use.
Listed Item
EchoMark LP is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.
Imaging Characteristics
Its polymeric construction has no clinically relevant magnetic properties, and the device is designated MR safe. Its purpose is to identify the treated soft tissue location for future visualization, without an active electronic or treatment function.
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 | Sonavex, Inc., United States |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Manufacturer |
| 510(k) | K180621 |
| Record published | 2018-12-06 |
| Record revised | 2023-09-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2000 | Small | In distribution |
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 |
| SecurMark for Atec | Hologic, Inc. | 15 |
| SenoMark® Ultra Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 14 |
| TriMark | Hologic, Inc. | 14 |
Showing 12 of 96. All products under Marker, Radiographic, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180621 | 2018-06-06 |
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.