Device Information

The Disposable Hemostatic Clips are used for endoscopic clip placement in the gastrointestinal tract. The clip is made of stainless steel with high superelasticity, and it can be opened and closed up to five times before deployment. Available in four widths—9 mm, 11mm, 13mm, and 16mm—this clip offers versatility in addressing various lesion sizes. The effective lengths are 1650mm, 1950mm, and 2300mm.

Indications for Use

This device is indicated for endoscopic clip placement within the gastrointestinal tract, including:

• Endoscopic marking
• Hemostasis for mucosal or sub-mucosal defects ❤ cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, diverticula in the colon
• Anchoring jejunal feeding tubes
• Supplemental closure for GI tract luminal perforations <20mm that can be treated conservatively

Intended Use

The Disposable Hemostatic Clips are intended for use by healthcare professionals trained in endoscopy to stop bleeding, close defects, and mark areas within the gastrointestinal tract.

Availability

This device is available by prescription only.

Study Results

• Nonclinical and Safety Testing: Bench tests such as dimensional verification, clamping force, and rotational performance were completed successfully. The device met all requirements of ISO 10993, ISO 11135-1, and ISO 10993-7, ensuring safety and biocompatibility.

Regulatory Information

• Regulation Number: 21 CFR 876.4400
• Regulatory Class: Class II
• Product Code: PKL
• 510(k) Number: K232450
• This device must comply with regulation 21 CFR Part 820 (Quality System regulation), ISO 10993 (Biological evaluation), and ISO 11135-1 (Sterilization processes for medical devices).

Manufacturer Information

• Name: Zhejiang Soudon Medical Technology Co., Ltd
• Address: Room 302-1, Building 4, No.1 Nangonghe Road, Donghu Street, Linping District, Hangzhou 311100 Zhejiang, China
• Contact Person: Nick Wang

Predicate Device Information

• Primary Predicate Device: Hemoclip (K172727) by Hangzhou AGS MedTech CO., Ltd
• Reference Device: Single Use Rotatable and Repositionable Hemoclip (K201771) by Anrei Medical (Hangzhou) Co., Ltd
• The Disposable Hemostatic Clips are designed similarly to the Hemoclip but have variations in clip width and working length. These changes do not raise safety or effectiveness concerns.

Implications

The device provides effective hemostasis in the gastrointestinal tract and can help treat various conditions such as ulcers and mucosal defects.

References

1. Disposable Hemostatic Clips. 510(k) Number: K232450. Zhejiang Soudon Medical Technology Co., Ltd: FDA summary link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K232450
2. https://www.soudonmed.com/

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