CONVIVO— 510(k) K181116

Substantially Equivalent

Carl Zeiss Meditec, AG

FDA 510(k) clearance K181116 for CONVIVO, Substantially Equivalent on 2018-10-25. Applicant: Carl Zeiss Meditec, AG.

Clearance details

Applicant: Carl Zeiss Meditec, AG
Product code: Code GWG
Advisory panel: Neurology
Date received: 2018-04-27
Decision date: 2018-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jena, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWG

product code GWG

Death: 5
Total: 5

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.