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FDA 510(k)

EmeryGlide™ (EG18008901)

K-Number: K253262 · 2026-03-06

ApplicantNano4imaging GmbH
Decision Date2026-03-06
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EmeryGlide™ (EG18008901) is the device name listed in this FDA 510(k) record. The listed applicant is Nano4imaging GmbH. It received FDA 510(k) clearance on 2026-03-06 under 510(k) number K253262. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EmeryGlide™ (EG18008901)?

EmeryGlide™ (EG18008901) is a medical device that received FDA 510(k) clearance on 2026-03-06. The listed applicant is Nano4imaging GmbH. The 510(k) number is K253262.

When did EmeryGlide™ (EG18008901) receive FDA 510(k) clearance?

EmeryGlide™ (EG18008901) received FDA 510(k) clearance on 2026-03-06, under 510(k) number K253262.

Who is the listed applicant for EmeryGlide™ (EG18008901)?

The FDA 510(k) record lists Nano4imaging GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EmeryGlide™ (EG18008901)?

The FDA product code for EmeryGlide™ (EG18008901) is DQX.

Other records listing Nano4imaging GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)Merit Medical Ireland, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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