FDA.reportPublic FDA data

Wovyn depth electrode

Primary DI
07290018179024
Brand
Wovyn depth electrode
Company
SENSO MEDICAL LABS LTD
Model
SEG-S121015-01
Device description
Wovyn Electrode: Contact #(12)/Electrode diameter (.8mm)/contact lengths(1.5mm) /contact spacing(1.0mm) /total length(400mm)
Published
2026-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GZLElectrode, Depth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZLElectrode, DepthNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253970000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253970000Wovyn Depth ElectrodeSensomedical Labs, Ltd.2026-04-17GZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018179024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018179024072900181790247290018179024

GMDN Terms#

Term, Definition table
TermDefinition
Depth electrodeAn electrical conductor intended to be temporarily placed (< 30 days) beneath the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a fine, flexible plastic device attached to wires that carry currents from deep and superficial brain structures. The wires are connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. The implant is particularly helpful in determining site of origin in temporal and frontal lobe epilepsy. This is a single-use device.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
600303230
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
true
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
07290018179000Wovyn depth electrodeSEG-S083515-012026-08-03
07290018179017Wovyn depth electrodeSEG-S101015-012026-08-03
07290018179031Wovyn depth electrodeSEG-S141015-012026-08-03
07290018179048Wovyn depth electrodeSEG-S141515-012026-08-03
07290018179055Wovyn depth electrodeSEG-S161515-012026-08-03
07290018179062Wovyn depth electrodeSEG-S142515-012026-08-03
07290018179079Wovyn depth electrodeSEG-S162515-012026-08-03
07290018179086Wovyn depth electrodeSEG-S163015-012026-08-03
07290018179093Wovyn depth electrodeSEG-S163815-012026-08-03
07290018179154C360 CableSEG-00CAB16-012026-08-03
07290018179161C360 CableSEG-00CAB17-012026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290018179000Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179017Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179031Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179048Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179055Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179062Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179079Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179086Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
07290018179093Wovyn depth electrodeSENSO MEDICAL LABS LTDGZL2026-08-03
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