About This 510(k) Submission
K252793 is an FDA 510(k) clearance for the 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), a Hysteroscope (and Accessories) (Class II — Special Controls, product code HIH), submitted by Jiangsu Jiyuan Medical Technology Co., Ltd. (Taizhou, CN). The FDA issued a Cleared decision on December 18, 2025, 111 days after receiving the submission on August 29, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.