About This 510(k) Submission
K210116 is an FDA 510(k) clearance for the Video Endoscopy System, 3D Video Endoscopy System, a Laparoscope, Gynecologic (and Accessories) (Class II — Special Controls, product code HET), submitted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (Cixi, CN). The FDA issued a Cleared decision on October 13, 2021, 267 days after receiving the submission on January 19, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1720.