Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Evry

K-Number: K200327 · 2020-04-29

ApplicantSynaptive Medical, Inc.
Decision Date2020-04-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Evry is the device name listed in this FDA 510(k) record. The listed applicant is Synaptive Medical, Inc.. It received FDA 510(k) clearance on 2020-04-29 under 510(k) number K200327. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Evry?

Evry is a medical device that received FDA 510(k) clearance on 2020-04-29. The listed applicant is Synaptive Medical, Inc.. The 510(k) number is K200327.

When did Evry receive FDA 510(k) clearance?

Evry received FDA 510(k) clearance on 2020-04-29, under 510(k) number K200327.

Who is the listed applicant for Evry?

The FDA 510(k) record lists Synaptive Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Evry?

The FDA product code for Evry is LNH.

Other records listing Synaptive Medical, Inc. 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.

K231986Modus IRK232981Synq Software Version 1.3K183325Modus NavK180394BrightMatter Plan 1.6.0K160523BrightMatter Guide with BrightMatter PointerK153281BrightMatter Guide with Surface Trace Registration

View all 8 devices →

Related Devices (Code: LNH)

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.

K253808AIR Recon DLGE Medical SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-scan Open (100001800)Esaote, S.p.A.

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.

↑