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)

510(k) number: K252793
Device name: 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)
Applicant: Jiangsu Jiyuan Medical Technology Co., Ltd. CN
Product code: HIH — Hysteroscope (And Accessories)
Decision date: 2025-12-18
Date received: 2025-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Obstetrics/Gynecology

PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K252793.pdf

Official FDA record: K252793

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.