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510(k) Data Aggregation
K Number
K102274Device Name
ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT
Manufacturer
ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES
Date Cleared
2011-06-15
(308 days)
Product Code
GAA
Regulation Number
878.4800Why did this record match?
Applicant Name (Manufacturer) :
ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mini-Lap Technologies RaviNeedle Aspiration Needle is indicated for use in endoscopic and open surgical procedures where it is appropriate to aspirate fluids and retain tissue during aspiration of fluids.
Device Description
The RaviNeedle Aspiration Instrument is stainless steel needle approximately 12 inches in overall length. The proximal end of the device is fitted with a luer adapter which is fitted to a standard syringe (not supplied with the device). Using the standard syringe, the device is used to aspirate small volumes of fluid during either open or laparoscopic procedures. The device has a chisel-point tip to allow for percutaneous application. To maintain the position of the needle tip during multiple aspirations, the distal end of the needle is equipped with expandable wire cage/balloon which secures the needle to small structures being aspirated (e.g., the gallbladder). Use of the security feature is optional on the part of the user.
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