RADIANCE ULTRA 32 4K ZEROWIRE DUO— 510(k) K222890

Substantially Equivalent

Nds Surgical Imaging, LLC

FDA 510(k) clearance K222890 for RADIANCE ULTRA 32 4K ZEROWIRE DUO, Substantially Equivalent on 2022-10-19. Applicant: Nds Surgical Imaging, LLC.

Clearance details

Applicant: Nds Surgical Imaging, LLC
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2022-09-23
Decision date: 2022-10-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

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.