# K203255: 4K UHD Laparoscope

- Pathway: 510(k) (Traditional)
- Applicant: Scivita Medical Technology Co., Ltd.
- Decided: Feb 24, 2021 after 112 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923982 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150633: ULTRA Telescopes, Olympus Winter & Ibe GmbH (2015) Summary page 6.

## Indications for use
The 4K UHD Laparoscope is intended to be used for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities including the female reproductive organs. The device is also indicated for visualization of transanal and transvaginal applications.

Source page: https://510kreport.com/device/K203255
Methodology: https://510kreport.com/methodology