Extension tube— 510(k) K251788

Substantially Equivalent

Zhuhai DR Medical Instruments Co., Ltd.

FDA 510(k) clearance K251788 for Extension tube, Substantially Equivalent on 2026-03-05. Applicant: Zhuhai DR Medical Instruments Co., Ltd..

Clearance details

Applicant: Zhuhai DR Medical Instruments Co., Ltd.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2025-06-11
Decision date: 2026-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhuhai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.