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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K254294
Device Name Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
Applicant
Zhejiang Geyi Medical Instrument Co., Ltd.
# 1, 2 Factory, # 5, Hutang Rd. Xiaya Town
Jiande City,  CN 311606
Applicant Contact Cathy Tan
Correspondent
Zhejiang Geyi Medical Instrument Co., Ltd.
# 1, 2 Factory, # 5, Hutang Rd. Xiaya Town
Jiande City,  CN 311606
Correspondent Contact Cathy Tan
Regulation Number884.1690
Classification Product Code
HIH  
Date Received12/31/2025
Decision Date 09/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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