Search Results
Found 1 results
510(k) Data Aggregation
K Number
K150549Device Name
Reactor(TM) Trocar and Sleeve
Manufacturer
Date Cleared
2015-06-01
(90 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Sharp Medical Prducts, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sharp Medical Reactor™ Trocar and Sleeve has indications in the creation of a port of entry into the thoracic cavity and allows the user to create and maintain limited access into the intention of chest tube placement.
Device Description
The Reactor™ Trocar consists of an obturator with a flat tip at the distal end which encloses a circular scalpel shaped knife blade. The blade extends approximately 1mm and immediately retracts when the trigger is squeezed. The clear sleeve with printing accommodates instruments up to 36 Fr. or 12 mm.
Ask a Question
Ask a specific question about this device
Page 1 of 1