Haemostasis Clips

The Haemostasis Clips are sterile, single-use endoscopic clipping devices used to deliver metal clips into the gastrointestinal tract. They are indicated for endoscopic marking, hemostasis of bleeding lesions and ulcers, anchoring feeding tubes, and supplementary closure of small perforations. The device consists of a handle and delivery catheter assembly (stainless steel and polyester) with a deployable stainless steel clip that can be opened and closed up to five times before final deployment.

The subject device and predicate (Hemoclip K172727) are identical in regulation number, class, product code, working length (1650–2350 mm), minimum channel diameter (2.8 mm), outer tube diameter (2.6 mm), sterilization method (ethylene oxide), and indications for use. The primary difference is clip opening width: the subject device offers 10, 12, and 15 mm widths versus the predicate's 9, 11, and 13 mm widths. Both use stainless steel (the subject uses SUS 631 and SUS 303 versus predicate's SUS 631 alone) and both are single-use, repositionable devices.

ISO 10993-1:2018 and FDA guidance for biocompatibility; ISO 10993 parts 4, 5, 6, 10, and 11 for cytotoxicity, sensitization, irritation, acute and chronic toxicity, hemolysis, and pyrogen testing. ISO 11135:2014 for ethylene oxide sterilization validation. Bench testing included appearance, size, opening/closing, rotation, clamping force, release force, hardness, corrosion, and breaking force per manufacturer's protocols.

The subject device shares identical indications, intended use, design principles, materials (stainless steel), sterilization method, and performance specifications with the predicate. Although the clip opening widths differ (10/12/15 mm vs. 9/11/13 mm), the difference is only dimensional; the largest model (15 mm) was tested and passed all bench requirements, demonstrating the wider clips do not raise safety or effectiveness concerns. Biocompatibility and sterilization testing confirm the device meets the same safety standards. The minor material variation (additional SUS 303 alloy) does not affect intended performance.