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FDA 510(k)

FOGLESS

K-Number: K923843 · 1994-03-25

ApplicantSorex Medical
Decision Date1994-03-25
Product CodeOCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FOGLESS is the device name listed in this FDA 510(k) record. The listed applicant is Sorex Medical. It received FDA 510(k) clearance on 1994-03-25 under 510(k) number K923843. 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 FOGLESS?

FOGLESS is a medical device that received FDA 510(k) clearance on 1994-03-25. The listed applicant is Sorex Medical. The 510(k) number is K923843.

When did FOGLESS receive FDA 510(k) clearance?

FOGLESS received FDA 510(k) clearance on 1994-03-25, under 510(k) number K923843.

Who is the listed applicant for FOGLESS?

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

What is the FDA product code for FOGLESS?

The FDA product code for FOGLESS is OCT.

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Other records listing Sorex Medical 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.

K913036PLUME MASTERK911070PICC-FIXK911150SOREX SAFE-AIRK910315PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.KK905572EDLICH WOUND MANAGEMENT TRAYK903740TRACH-EZE

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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.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, LLC

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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