Disposable Grasping Forceps FG-52D/FG-54D

The Disposable Grasping Forceps FG-52D/FG-54D are single-use, sterile devices designed to retrieve foreign bodies, calculus, or tissue specimens from the tracheobronchial tree during bronchoscopy. Each device consists of a handle with a control ring and an insertion portion with a grasping head available in two shapes: spiral basket type (FG-52D) or three-nail type (FG-54D), both made of stainless steel.

The subject device has a maximum insertion portion diameter of 0.8 mm (FG-52D) or 1.05 mm (FG-54D), working length of 1150 mm, and opening widths of 8 mm or 10 mm respectively. It is compatible with endoscopes having working length less than 700 mm and channel inner diameters of 1.2–3.2 mm. Both models are sterilized via ethylene oxide and are single-use devices, identical in sterilization and reusability to the predicate but differing in insertion diameter, working length, opening width, and grasping shape.

Biocompatibility per ISO 10993-1:2018 (including cytotoxicity, sensitization, irritation, acute systemic toxicity); sterilization validation per ISO 11135:2014; ethylene oxide residuals per ISO 10993-7:2008; packaging and shelf-life per ISO 11607-1:2019 and ASTM F1980-16; mechanical testing including insertion/withdrawal force, handle operation, grasping performance, strength testing, and device reliability.

The subject device and predicate device share the same intended use (removing materials from the tracheobronchial tree via endoscope), sterilization method (ethylene oxide), and single-use design. Although the subject device differs in insertion portion diameter, working length, opening width, and grasping portion shape, these differences do not raise new safety or effectiveness questions because they are addressed through comprehensive bench testing demonstrating equivalent performance. The non-clinical performance data show the subject device is as safe and effective as the predicate device.