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510(k) Data Aggregation
K Number
K223300Device Name
Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument
Manufacturer
Date Cleared
2023-04-21
(176 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
GEOTEK Medikal Ltd sti
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Geotek Disposable Core Biopsy Needles (Three Models: Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, and Maxicore-M Automatic Biopsy Needle and Instrument) are intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not Intended for use in bone.
Device Description
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K Number
K170741Device Name
GTK Disposable Needle Guides
Manufacturer
Date Cleared
2017-06-01
(83 days)
Product Code
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
GEOTEK Medikal Ltd Sti
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GTK Disposable Needle Guides when used in conjunction with ultasound system transducer where configuration is suitable (e.g. Aloka, Alpinion, BK, Esaote, GE, Hitachi, Mindray, Philips, Toshiba, Siemens, and Shimadzu ultrasound systems) and attached to the ultrasound system's transducers, is to facilitate proper needle placement to access anatomical structures.
Device Description
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