Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF)— 510(k) K233840

Name: FDA 510(k) clearance K233840
Creator: U.S. Food and Drug Administration
Published: 2024-06-26

Substantially Equivalent

Zhuhai Dipu Medical Technology Co., Ltd.

FDA 510(k) clearance K233840 for Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF), Substantially Equivalent on 2024-06-26. Applicant: Zhuhai Dipu Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhuhai Dipu Medical Technology Co., Ltd.
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-12-04
Decision date: 2024-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhuhai, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code GCJ

view all

K263459 — SWICS2026-10-29
K262455 — da Vinci 5 Handheld Camera Head (470080) +4 more2026-10-14
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

More clearances from Zhuhai Dipu Medical Technology Co., Ltd.

view all

K233892 — 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF)2024-06-13

Adverse events under product code GCJ

product code GCJ

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.