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FDA 510(k)

E-Brik Visualization Assistant

K-Number: K221293 · 2022-07-07

ApplicantJdi Surgical, Inc.
Decision Date2022-07-07
Product CodeOCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

E-Brik Visualization Assistant is the device name listed in this FDA 510(k) record. The listed applicant is Jdi Surgical, Inc.. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K221293. The device is classified under product code OCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-Brik Visualization Assistant?

E-Brik Visualization Assistant is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Jdi Surgical, Inc.. The 510(k) number is K221293.

When did E-Brik Visualization Assistant receive FDA 510(k) clearance?

E-Brik Visualization Assistant received FDA 510(k) clearance on 2022-07-07, under 510(k) number K221293.

Who is the listed applicant for E-Brik Visualization Assistant?

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

What is the FDA product code for E-Brik Visualization Assistant?

The FDA product code for E-Brik Visualization Assistant is OCT.

Related Devices (Code: OCT)

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.

K251068KnoxFog Anti-fogging DeviceUv One Hygienics, Inc.K231822GOLFF Sterile Anti-Fog SolutionBatrik Medical Manufacturing, Inc.K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal UrunlerK181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd.K163257VitreOx Anti-fog SolutionSio2 Nanotech, LLCK152948Medline Anti-Fog SolutionMedline Industries, Inc.

Official Source

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

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