(84 days)
The Avail Sterile, Latex Free, Water Filled Syringe is intended to be used to provide sterile water for catheter inflation after insertion.
The Avail Sterile, Latex Free, Water Filled Syringe is a sterile, single patient use, disposable device that is substantially equivalent to the predicate device and other pre-filled syringes. The device is designed for catheter inflation only and is intended for single patient use as was the predicate device.
The provided text does not contain information about acceptance criteria, device performance, or a study proving that a device meets acceptance criteria. The documents are a 510(k) summary and an FDA clearance letter for a pre-filled catheter inflation syringe. They focus on establishing substantial equivalence to a predicate device and outlining regulatory information.
Therefore, I cannot populate the requested tables and information based on the provided text.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.