Nuvis® Wireless HD Camera System (Nuvis-2K)— 510(k) K242606

Substantially Equivalent

Integrated Endoscopy, Inc.

FDA 510(k) clearance K242606 for Nuvis® Wireless HD Camera System (Nuvis-2K), Substantially Equivalent on 2025-11-20. Applicant: Integrated Endoscopy, Inc..

Clearance details

Applicant: Integrated Endoscopy, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2024-08-30
Decision date: 2025-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.