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510(k) Data Aggregation
K Number
K231877Device Name
NavaClick Injection System
Manufacturer
Date Cleared
2023-11-30
(157 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Lineage Biomedical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NavaClick Injection System is intended for injection of fluids into the body. It is specifically indicated for injection of botulinum neurotoxin, consistent with the neurotoxin's approved labeling.
Device Description
The NavaClick Injector is a manually-operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer-lock connector into which is inserted a closely-fitted, ratcheted, moveable plunger. The syringe is printed with a graduated scale (1 mL volume), and has audible and tactile feedback upon delivery of each 0.02 mL fluid. The syringe has been designed to enhance the efficiency and precision of neurotoxin injections.
The syringe has been packaged with other components for convenience. The NavaClick Injection System is a kit containing the NavaClick Injectors (syringes), needles, and a vial adapter for delivery of neurotoxin per the labeled indication.
The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.
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