ArthroFree Wireless Surgical Camera System— 510(k) K213860

Substantially Equivalent

Lazurite Holdings, LLC

FDA 510(k) clearance K213860 for ArthroFree Wireless Surgical Camera System, Substantially Equivalent on 2022-03-23. Applicant: Lazurite Holdings, LLC.

Clearance details

Applicant: Lazurite Holdings, LLC
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2021-12-10
Decision date: 2022-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, 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.