SGH · Class II · 21 CFR 892.1560

FDA Product Code SGH: Ultrasound Imaging For Vascular Access For Hemodialysis

Ultrasound Imaging For Vascular Access For Hemodialysis

Leading manufacturers include X9, Inc..

1
Total
1
Cleared
140d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Ultrasound Imaging For Vascular Access For Hemodialysis Devices (Product Code SGH)

1 devices
1–1 of 1
Cleared Oct 17, 2025
X9 Ultrasound System
K251673
X9, Inc.
Gastroenterology & Urology · 140d

About Product Code SGH - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SGH since 2025, with 1 receiving FDA clearance (average review time: 140 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SGH devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →