EmeryGlide (EG18008901)— 510(k) K253262

Substantially Equivalent

Nano4imaging GmbH

FDA 510(k) clearance K253262 for EmeryGlide (EG18008901), Substantially Equivalent on 2026-03-06. Applicant: Nano4imaging GmbH.

Clearance details

Applicant: Nano4imaging GmbH
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2025-09-29
Decision date: 2026-03-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Duesseldorf, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.