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510(k) Data Aggregation
K Number
K050135Device Name
K-C HEMOSTATIC BIOPSY SYSTEM
Manufacturer
Date Cleared
2005-07-13
(173 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
BIOENGINEERING CONSULTANTS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The K-C Hemostatic Biopsy System is indicated for use endoscopically or percutaneous to retrieve tissue sampling of soft organs/tumors or masses for histological analysis and deliver a hemostatic material to the biopsy site to reduce bleeding from the biopsy site. Soft tissue sampling includes but not limited to organs such as breast, liver, kidney and prostate. It is not intended for use in bone.
Device Description
The proposed device consists of a mechanism to capture a biopsy sample of soft tissue, soft organs, tumor or masses for histological analysis and a co-axially configured syringe containing a hemostatic agent to be delivered into the biopsy tract upon removal of the biopsy sample.
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