FDA.reportPublic FDA data

EchoMark LP

Primary DI
B53620001
Brand
EchoMark LP
Company
SONAVEX, INC.
Model
2000
Device description
EchoMark LP is an implantable ultrasound surgical site marker for soft tissue. The marker is comprised of a bioresorbable polymer.
Published
2018-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180621000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180621000EchoMark, EchoMark LPSonavex, Inc.2018-06-06NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B53620001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. It is not an electromagnetic or optical spatial marker.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
(443)862-2024contact@sonavex.com

Regulatory Flags#

DUNS number
079208177
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B53630001EchoMark30002018-12-06
B53670000EchoSure70002026-04-14
B53690000EchoMap90002026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841911103363HydroMarkDEVICOR MEDICAL PRODUCTS, INC.NEU2025-10-02
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01