# K210116: Video Endoscopy System, 3D Video Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Decided: Oct 13, 2021 after 267 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931154 (1993). 38 ancestors in all.
No later device cites it as a predicate yet.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150525: SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link, KARL STORZ Endoscopy-America, Inc. (2015) Summary page 4.

## Indications for use
The Video Endoscopy System &3D Video Endoscopy System are intended to be used to provide illumination and visualization of surgical field in a wide variety of diagnostic and therapeutic abdominal and thoracic minimally invasive procedures, including female reproductive organs (gynecology) and urological anatomy.

Source page: https://510kreport.com/device/K210116
Methodology: https://510kreport.com/methodology