Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)— 510(k) K243155

Substantially Equivalent

Dongguan Zsr Biomedical Technology Company Limited

FDA 510(k) clearance K243155 for Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04), Substantially Equivalent on 2025-02-11. Applicant: Dongguan Zsr Biomedical Technology Company Limited.

Clearance details

Applicant: Dongguan Zsr Biomedical Technology Company Limited
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-30
Decision date: 2025-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.