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FDA 510(k)

GOLFF Sterile Anti-Fog Solution

K-Number: K231822 · 2024-02-26

ApplicantBatrik Medical Manufacturing, Inc.
Decision Date2024-02-26
Product CodeOCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GOLFF Sterile Anti-Fog Solution is the device name listed in this FDA 510(k) record. The listed applicant is Batrik Medical Manufacturing, Inc.. It received FDA 510(k) clearance on 2024-02-26 under 510(k) number K231822. 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 GOLFF Sterile Anti-Fog Solution?

GOLFF Sterile Anti-Fog Solution is a medical device that received FDA 510(k) clearance on 2024-02-26. The listed applicant is Batrik Medical Manufacturing, Inc.. The 510(k) number is K231822.

When did GOLFF Sterile Anti-Fog Solution receive FDA 510(k) clearance?

GOLFF Sterile Anti-Fog Solution received FDA 510(k) clearance on 2024-02-26, under 510(k) number K231822.

Who is the listed applicant for GOLFF Sterile Anti-Fog Solution?

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

What is the FDA product code for GOLFF Sterile Anti-Fog Solution?

The FDA product code for GOLFF Sterile Anti-Fog Solution 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.K221293E-Brik Visualization AssistantJdi Surgical, 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

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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