URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor)— 510(k) K240203

Substantially Equivalent

Dyne Medical Group, Inc.

FDA 510(k) clearance K240203 for URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor), Substantially Equivalent on 2024-09-05. Applicant: Dyne Medical Group, Inc..

Clearance details

Applicant: Dyne Medical Group, Inc.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2024-01-25
Decision date: 2024-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi-Do, KR

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.