Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P

The Single Use Retrieval Basket V is a sterile, single-use medical device designed to retrieve stones from the biliary tract during endoscopic procedures. It consists of a handle and an insertion portion with either an 8-wire or 4-wire basket configuration, made from stainless steel, and is compatible with Olympus endoscopes.

The subject device offers four models (FG-V421PR, FG-V422PR, FG-V431P, FG-V432P) with variations in opening width (20 mm or 22 mm), insertion portion diameter (2.4 mm or 2.9 mm), wire configuration (8-wire or 4-wire), and basket function (rotatable or distal wire-guided). All models have a 1900 mm working length and require a minimum 4.2 mm channel size, compared to the predicate's 3.7 mm requirement.

ISO 10993-1:2018 (biocompatibility including cytotoxicity, sensitization, irritation, acute systemic toxicity, and pyrogenicity); ISO 11135:2014 (sterilization validation); ISO 11607-1:2019 and ASTM F1980-21 (packaging validation and shelf life testing); mechanical testing per unspecified bench standards for insertion, withdrawal, basket operation, and grasping effectiveness.

The subject device shares the same intended use as the predicate device (stone retrieval from biliary tract). Design differences—including introduction of rotatable baskets, 22 mm opening width, 2.4 mm insertion diameter, 4-wire configuration, and stainless steel material—do not raise new safety or effectiveness concerns because they represent incremental design variations common in the device class. Non-clinical testing (biocompatibility, sterilization, mechanical performance) demonstrates these variations maintain performance equivalence, and reference device testing supports the rotatable basket function.