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510(k) Data Aggregation
K Number
K041544Device Name
COOK SIDEARM CORE TISSUE BIOPSY DEVICE
Manufacturer
UROLOGICAL INC.
Date Cleared
2004-07-22
(43 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
UROLOGICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cook® Sidearm Core Tissue Biopsy Device/Set is used as an automated biopsy instrument to obtain multiple cores of tissue sampling from sites including, but not limited to the prostate, kidney, liver, lung, breast, lymph nodes, and different tumors for histological evaluation.
Device Description
The Cook® Sidearm Core Tissue Biopsy Device/Set is used as an automated biopsy instrument to obtain multiple core tissue sampling from sites including, but not limited to, the prostate, kidney, liver, lung, breast, lymph nodes and different tumors for histological evaluation. The Cook® Sidearm Core Tissue Biopsy Device/Set allows adjustment for an 18mm or 23mm sample, allows the sample to be easily exposed, is a one-handed operation, and will not fire when the sample size is in the incorrect position. The construction of the Cook® Sidearm Core Tissue Biopsy Device is Ryton, Anodized aluminum, Silicone, Delrin, and Stainless Steel. The construction of the Cook® Sidearm Needles are stainless steel and polycarbonate.
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