Search Results
Found 1 results
510(k) Data Aggregation
K Number
K103668Device Name
BNX FINE NEEDLE ASPIRATION SYSTEM
Manufacturer
Date Cleared
2010-12-30
(14 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
BOSTON ENDOSCOPIC ENGINEERING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BNX™ Fine Needle Aspiration System is used to sample targeted sub-mucosal and extramural lesions of the gastrointestinal tract through the accessory channel of an ultrasound endoscope.
Device Description
The BNXTM Fine Needle Aspiration System is a sterile, single patient use endoscopic ultrasound aspiration needle. The device consists of the BNXTM Aspiration Delivery System and BNXTM Fine Needle Aspiration Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The needle is used to acquire aspiration samples from lesions targeted using an ultrasound endoscope. An aspiration sample is obtained by penetrating the lesions with the needle while applying suction. The device will be offered with needle sizes of 19, 22 and 25 gauge.
Ask a Question
Ask a specific question about this device
Page 1 of 1