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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 K252584
Device Name Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)
Applicant
Weyo Surgical Technology , Ltd.
Rm. 313, Bldg. 3, 56 Ling Zhi Rd., Xuan Wu District
Nanjing,  CN 210000
Applicant Contact Jianfeng Wang
Correspondent
APlus Healthcare Technology (Shanghai) Co., Ltd.
1201 Floor, Zhongzhi Bldg., #9299 Humin Rd., Xuhui Dis
Shanghai,  CN 200030
Correspondent Contact Jack Fang
Regulation Number884.1730
Classification Product Code
HIF  
Date Received08/15/2025
Decision Date 06/25/2026
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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