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 a medical device manufactured by Batrik Medical Manufacturing, Inc.. It received FDA 510(k) clearance on 2024-02-26 under approval 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. It is manufactured by Batrik Medical Manufacturing, Inc.. The 510(k) number is K231822.

When was GOLFF Sterile Anti-Fog Solution approved by the FDA?

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

What company makes GOLFF Sterile Anti-Fog Solution?

GOLFF Sterile Anti-Fog Solution is manufactured by Batrik Medical Manufacturing, Inc..

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)

K152948Medline Anti-Fog SolutionMedline Industries, Inc. K163257VitreOx Anti-fog SolutionSio2 Nanotech, LLC K181887AMD Anti-Fog SolutionAdvanced Medical Design Co., Ltd. K190864Konix Anti-Fog SolutionTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler K221293E-Brik Visualization AssistantJdi Surgical, Inc. K251068KnoxFog Anti-fogging DeviceUv One Hygienics, 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.