FDA 510(k) Application Details - K221995

Device Classification Name	Insufflator, Laparoscopic   More FDA Info for this Device
510(K) Number	K221995
Device Name	Insufflator, Laparoscopic
Applicant	Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area Zonghan Subdistrict Cixi 315300 CN Other 510(k) Applications for this Company
Contact	Guofang Ma Other 510(k) Applications for this Contact
Regulation Number	884.1730   More FDA Info for this Regulation Number
Classification Product Code	HIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2022
Decision Date	03/28/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review