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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K232401
Device Name Disposable Veress Needles
Applicant
Hangzhou Kangji Medical Instrument Co., Ltd.
# 1668 Chunjiang E. Rd., Economic Development Zone
Tonglu
Hangzhou,  CN 311501
Applicant Contact Martin Sun
Correspondent
Shanghai Lingfu Technology Co., Ltd.
4f # 585-2, Wanyuan Rd. Minhang District
Shanghai,  CN 201102
Correspondent Contact Esther Zhang
Regulation Number884.1730
Classification Product Code
HIF  
Subsequent Product Code
FHO  
Date Received08/10/2023
Decision Date 12/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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