September 510K Clearance Highlights

Accel Groups select ten medical devices or in vitro diagnostic reagents from the monthly 510(k) clearance list (five from Chinese manufacturers and five from foreign manufacturers) for brief introductions. This aims to provide the latest global updates on medium and low-risk devices or reagents. If you have similar devices you wish to bring to the US market, please contact us at info@accelgroups.com.

Chinese Manufacturers

1. Ultrasound Diagnosis System, Mindray Medical International Limited
   Various bedside devices provide physiological information, including ultrasound imaging, ECG signals, and respiratory signals. This system integrates these data to offer a new perspective on the patient’s condition. It not only brings high clinical value and accurate diagnosis to daily practice but also assists in multidisciplinary treatment (MDT) and advanced multimodal clinical research.
2. Aseptic Ultrasound Coupling Gel, Anhui Deep Blue Medical Technology Co., Ltd.
   This product is a water-based polymer gel formulation, mainly composed of carbomer, triethanolamine, propylene glycol, glycerin, triclosan, and purified water. It is used as a medium for transmitting sound waves during ultrasound diagnosis or treatment, applied between the skin and the probe’s surface to improve ultrasound coupling between the probe and the patient’s skin, and also has a skin disinfecting function.
3. Pneumatic Leg Massager, Zhangzhou Mengfali Industrial Co., Ltd.
   The leg massager provides pressure to the feet, calves, and thighs, helping to relieve muscle pain and improve blood circulation.
4. Electric Wheelchair, Ningbo Youhuan Automation Technology Co., Ltd.
   Based on the traditional manual wheelchair, this model is upgraded with a high-performance power drive system, smart control devices, batteries, and other components. It is powered by rechargeable lithium batteries, compact, lightweight, and energy-efficient.
5. Disposable High-Pressure Angiographic Syringe, Beijing Chaosi Electronic Technology Co., Ltd.
   Used for CT, MR, and DSA—suitable for computed tomography, angiography, magnetic resonance, and imaging. The contrast agent it carries is the gold standard for identifying cancerous tissues and produces high-definition images of lesions. It can withstand pressures up to 350 Pa or 1200 Pa, offering excellent heat and pressure resistance, good breathability, and a transparent body that provides clarity for detecting bubbles and contrast agent.

Foreign Manufacturers

1. Lumbar Facet Fixation Device, ZygoFix Ltd.
   Utilizes the innate skeletal structure of the spine to securely lock its connecting joints. Unlike traditional methods, this company’s innovative implant adapts to the joint’s anatomical structure during insertion, providing unmatched stability. It is a minimally invasive and straightforward procedure that can be performed in outpatient and ASC settings.
2. Access and Aspiration Catheters, Perfuze Ltd.
   Quickly and safely removes blood clots. The device is designed to offer excellent delivery capabilities and high surgical efficiency. Its ribbed surface structure improves navigation and reduces tip stiffness while maintaining durability.
3. Liver Ultrasound System, Supersonic Imagine
   A fast, non-invasive, repeatable examination that provides quantitative measurements of liver tissue stiffness and color-coded maps on anatomical B-mode images.
4. Lateral Expandable Interbody System, Alphatec Spine Inc.
   This lateral expandable interbody system is designed to provide continuous expansion for restoring spinal lordosis and intervertebral height through various unique expandable implants and plate products. The Calibrate LTX system is designed for simple and easy insertion, seamlessly integrating into ATEC’s lateral platform.
5. Peripheral Nerve Stimulator, Nalu Medical Inc.
   With the Nalu system, most patients are unaware of the electrical pulses. A small number of patients may experience a slight tingling sensation, known as paresthesia. Thin wires (called leads) are placed under the skin near the nerves associated with the pain, and an implanted pulse generator (IPG) is placed under the skin and connected to the leads to deliver electrical pulses.

About Accel

Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.