EmeryGlide (EG18008901)— 510(k) K253262
Substantially EquivalentNano4imaging GmbH
FDA 510(k) clearance K253262 for EmeryGlide (EG18008901), Substantially Equivalent on 2026-03-06. Applicant: Nano4imaging GmbH. Device class: 2.
Summary
Nano4imaging's EmeryGlide (EG18008901) is filed under DQX, catheter guide wires. The record doesn't describe the guidewire beyond its name and that code name.
Class II, 21 CFR 870.1330. It was a Special 510(k), and Cardiovascular is both the classification panel and the review panel.
Nano4imaging filed from Duesseldorf, Germany. The decision came 158 calendar days after FDA received it (September 29, 2025 to March 6, 2026).
Clearance details
- Applicant
- Nano4imaging GmbH
- Product code
- Product code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Duesseldorf, DE
Recent devices under product code DQX
view allMore clearances from Nano4imaging GmbH
view allAdverse 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, through . 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.