Disposable Endoscopic Injection Needles

The Disposable Endoscopic Injection Needle is a single-use medical device designed to be used with an endoscope to perform submucosal injections in the digestive tract. It consists of a handle assembly, inner and outer tubes, an introducer, and a needle tip assembly. The device is sterilized using ethylene oxide gas and has a shelf life of 3 years.

The proposed device has similar design features to the predicate device (K213914), including the same product code (FBK), regulatory classification (Class II), and indication for use. It uses the same sterilization method (EO), achieves the same sterility assurance level (SAL 10-6), and has comparable materials. The needle sizes (21G, 23G, 25G) and working lengths (1200–2300 mm) overlap with the predicate, though the predicate offers additional size options.

ISO 10993-4:2017, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2021, ISO 10993-11:2017, ISO 10993-23:2021, ASTM F1980-16, ASTM F88/88M-15, ASTM F1929-15, ASTM F1886-16, and USP <85> Bacterial Endotoxins Test.

The proposed device is substantially equivalent to the predicate because it has the same indication for use, similar design and construction, equivalent technological characteristics, and meets the same biocompatibility and sterilization standards. Performance testing data demonstrates that the proposed device has the same safety and effectiveness profile as the predicate device.