Search Results
Found 1 results
510(k) Data Aggregation
K Number
K190168Device Name
Aquas Probes
Manufacturer
Genicon, Inc.
Date Cleared
2019-03-14
(42 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Genicon, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GENICON Aquas Probes are instruments insulated for optional monopolar coagulation which enable a surgeon to manipulate, cut, or coagulate internal tissue or organs while performing laparoscopic procedures.
Device Description
The GENICON Aquas Probes product line are multiple-use provided nor-sterile. The probes are insulated for optional monopolar coagulation which enables a surgeon to manipulate, cut, or coagulate soft tissue or organs while performing laparoscopic procedures. The GENICON Aquas Probes have an outside diameter of 5 mm and are provided in varying lengths and tip configurations. Working lengths range from 20 to up to 45 cm. Common tip configurations include L-Hook (Right Angle), J-Hook, Spatula, 45 Deg, Knife, Ball, Needle, and Spoon. Devices may also include a channel for suction and irrigation of sterile irrigant solution when attached to a compatible lavage device. Devices may also include retractable insulation and insulation at the digression of the user. Device are intended to be reused up to 50 times, and may be sterilized by high-pressure steam autoclave.
Ask a Question
Page 1 of 1