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510(k) Data Aggregation
K Number
K103326Device Name
MULTIPLE BIOPSY SYSTEMManufacturer
Date Cleared
2011-04-06
(145 days)
Product Code
Regulation Number
876.1075Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
MULTIPLE BIOPSY SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Multiple Biopsy System is intended to be used with a suction source to collect biopsy samples from the upper and lower gastrointestinal tract for microscopic examination.
Device Description
Not Found
AI/ML Overview
This is a letter for a 510(k) premarket notification for a "Multiple Biopsy System". This document does not contain information about acceptance criteria or a study proving device performance, as it is a regulatory clearance letter rather than a scientific study or performance report.
Therefore, I cannot extract the requested information from the provided text.
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