Home / 510(k) Clearances / K252793

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2025
Date Received
August 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Jiangsu Jiyuan Medical Technology Co., Ltd.

  • K210270 — Medical Endoscope Image Processing System (October 1, 2021)

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