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510(k) Data Aggregation
K Number
K231422Device Name
Precision GI
Manufacturer
Limaca Medical Ltd
Date Cleared
2023-08-28
(103 days)
Product Code
FCG
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
Limaca Medical Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Precision GI is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.
Device Description
The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a motorized, automated, rotational, cutting EUS-Biopsy needle with an echogenic tip inserted and operated through the instrument channel of an ultrasound imaging endoscope.
The Limaca Precision GI FNB needle is available in one size - 20G.
The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a battery-operated, motorized, automated rotational cutting biopsy device with an echogenic needle tip, advanced and operated by the physician through the accessory instrument channel of an ultrasound imaging endoscope.
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