Disposable Hemoclip

No FDA recalls found in the data synced 23 Oct 2026.

510(k) Number

K230004 ↗

FDA product code

PKL

FDA applicant

Yangzhou Fartley Medical Instrument Technology Co., Ltd.

Device class

Class II

Regulation

21 CFR Part 876.4400

Advisory committee

Gastroenterology, Urology

FDA decision

SESE Substantially Equivalent

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See all devices from Yangzhou Fartley Medical Instrument Technology Co., Ltd →

• Are these hemoclips reusable or intended for single-use only, and why does that matter in a clinical setting?

  The Disposable Hemoclip is explicitly designed for single-use only, as stated in the product description. This matters clinically because single-use devices eliminate the risk of cross-contamination between patients, reducing infection risks and ensuring consistent performance. Since they are supplied sterile and require no reprocessing, clinicians can rely on their reliability without additional sterilization steps.

• What types of procedures are these hemoclips primarily used for, and how do they help during those procedures?

  These hemoclips are primarily used in gastrointestinal (GI) and urological procedures, such as polypectomy or anastomosis, where controlling bleeding is critical. They apply controlled pressure to occlude blood vessels or ducts, effectively achieving hemostasis—meaning they stop bleeding during surgery. This helps reduce intraoperative blood loss and improves surgical outcomes by maintaining a clear field for the surgeon.

• How do I know which size or model of hemoclip to order for a specific procedure, and are there multiple sizes available?

  The Disposable Hemoclip comes in multiple sizes and configurations, with each model tailored for specific clinical applications. While the exact sizes aren’t detailed in the provided data, the product is categorized under FDA product codes (e.g., 1037905, 3013557562), which implies variability in dimensions. Clinicians should consult the manufacturer’s technical documentation or surgical guidelines to select the appropriate size based on the anatomical site and vessel/duct diameter being treated.

• Do these hemoclips require any special handling or storage conditions, and how long can they be stored before use?

  The Disposable Hemoclip is supplied sterile, so it must be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain sterility and integrity. While the exact shelf life isn’t specified, single-use medical devices like these typically have a defined expiration date printed on the packaging. Always follow the manufacturer’s storage instructions and expiration guidelines to ensure safety and effectiveness before use.

• What regulatory pathways have these hemoclips gone through, and how does that affect their use in clinical practice?

  The Disposable Hemoclip has undergone FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for safety and effectiveness. This means it has been evaluated by the FDA as substantially equivalent to a predicate device and aligns with European medical device regulations. Clinicians can trust its design and performance based on these approvals, though they should always follow local regulatory and institutional protocols for procurement and use.