510(k) K252793

ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) by Jiangsu Jiyuan Medical Technology Co., Ltd. — Product Code HIH

K252793 is an FDA 510(k) premarket notification submitted by Jiangsu Jiyuan Medical Technology Co., Ltd. for the device "ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C)". The FDA issued a decision of Substantially Equivalent on December 18, 2025. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Jiangsu Jiyuan Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.