4K UHD Laparoscope— 510(k) K203255

Clearance details

Applicant

Scivita Medical Technology Co., Ltd.

Product code

Code GCJ

Device class

Class 2

Regulation

21 CFR 876.1500

Advisory panel

Gastroenterology, Urology

Date received

2020-11-04

Decision date

2021-02-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Suzhou, CN

• K262397 — CuratOR EX27422026-09-11
• K260884 — UNIDRIVE Select System2026-09-01
• K260972 — OEV-271MUH LCD Monitor; OEV-321MUH LCD Monitor; OEV-431MUH LCD Monitor2026-08-26
• K261139 — VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)2026-08-13
• K253541 — EZ-Close (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)2026-07-24

• K262552 — Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)2026-08-14
• K251338 — Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G +1 more2026-01-20
• K243708 — Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P +2 more2025-03-27
• K250210 — Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) +2 more2025-03-19
• K240289 — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D)2024-10-23

Death

39

Injury

1,638

Malfunction

28,216

Other

11

Total

29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →