FDA.reportPublic FDA data

Vescut Automatic Biopsy Needle

Primary DI
08699158346348
Brand
Vescut Automatic Biopsy Needle
Company
GEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETI
Model
GVS1415
Catalog number
GVS1415
Device description
This is a guillotine type automatic biopsy needle with a stylet with sample notch and a cm marked echogenic cutting cannula.
Published
2026-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223300000Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and InstrumentGeotek Medikal Ltd Sti2023-04-21KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08699158346348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08699158346348086991583463488699158346348

GMDN Terms#

Term, Definition table
TermDefinition
Side-notch biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Storage environment temperature between 5-30 degrees celsius

Contacts#

Phone, Email table
PhoneEmail
(908)699-0662info@geotekmedicalusa.com

Regulatory Flags#

DUNS number
503024386
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08681672055950Vescut Automatic Biopsy NeedleGVS2016GVS20162026-05-04
08681672055974Vescut Automatic Biopsy Needle w/coaxialGVS2009-XGVS2009-X2026-05-04
08681672055981Vescut Automatic Biopsy Needle w/coaxialGVS2016-XGVS2016-X2026-05-04
08683255230259Vescut Automatic Biopsy NeedleGVS1412GVS14122026-05-04
08683255230266Vescut Automatic Biopsy NeedleGVS1612GVS16122026-05-04
08683255230273Vescut Automatic Biopsy NeedleGVS1812GVS18122026-05-04
08683255230280Vescut Automatic Biopsy NeedleGVS2009GVS20092026-05-04
08683255230297Vescut Automatic Biopsy Needle w/coaxialGVS1412-XGVS1412-X2026-05-04
08683255230303Vescut Automatic Biopsy Needle w/coaxialGVS1612-XGVS1612-X2026-05-04
08683255230310Vescut Automatic Biopsy Needle w/coaxialGVS1625-XGVS1625-X2026-05-04
08683255230327Vescut Automatic Biopsy Needle w/coaxialGVS1812-XGVS1812-X2026-05-04
08683255230334Vescut Automatic Biopsy Needle w/coaxialGVS1825-XGVS1825-X2026-05-04
08683255230341Vescut Automatic Biopsy Needle w/coaxialGVS2020-XGVS2020-X2026-05-04
08699158346300Vescut Automatic Biopsy NeedleGVS1409GVS14092026-05-04
08699158346317Vescut Automatic Biopsy Needle w/coaxialGVS1409-XGVS1409-X2026-05-04
08699158346324Vescut Automatic Biopsy NeedleGVS1410GVS14102026-05-04
08699158346331Vescut Automatic Biopsy Needle w/coaxialGVS1410-XGVS1410-X2026-05-04
08699158346355Vescut Automatic Biopsy Needle w/coaxialGVS1415-XGVS1415-X2026-05-04
08699158346362Vescut Automatic Biopsy NeedleGVS1416GVS14162026-05-04
08699158346379Vescut Automatic Biopsy Needle w/coaxialGVS1416-XGVS1416-X2026-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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