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510(k) Data Aggregation
K Number
K013006Device Name
OVUS CAPLESS SAFETY NEEDLE
Manufacturer
Date Cleared
2002-02-06
(153 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
OVUS SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OVUS Capless Safety Needle, when used with a standard commercially available syringe, is intended to inject fluids into, or withdraw fluids from, parts of the body, including the applications of hypodermic injection, veinipuncture, and drawing of arterial blood. The needle is retracted after use to prevent accidental needle sticks.
Device Description
The OVUS Capless Safety Needle is a retractable needle system that provides anti-sharps protection. The device is made of the following components: (1) a slotted plastic housing, (2) a needle with a tab on the hub that protrudes from the slot in the housing when installed, (3) a spring that fits over the metal needle shaft, (4) a collar bonded to the proximal end of the housing to prevent the needle from sliding out, (5) a locking pin to prevent reuse (tamper-proof version only), and (6) a dust cover for the distal end of the device. The housing has a slot that allows the tab on the needle hub to slide toward the distal end and into the extended position with the needle fully exposed. At each end of the slot there is a short perpendicular slot that serves to lock the needle/tab in either the fully retracted or fully extended position. When extended, the spring is compressed and would tend to retract the needle unless it were locked in the extended position.
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