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FDA 510(k)

Titan Ag 200

K-Number: K173844 · 2018-08-09

ApplicantSpecialty Fibres and Materials, Ltd.
Decision Date2018-08-09
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

Titan Ag 200 is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Fibres and Materials, Ltd.. It received FDA 510(k) clearance on 2018-08-09 under 510(k) number K173844. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Titan Ag 200?

Titan Ag 200 is a medical device that received FDA 510(k) clearance on 2018-08-09. The listed applicant is Specialty Fibres and Materials, Ltd.. The 510(k) number is K173844.

When did Titan Ag 200 receive FDA 510(k) clearance?

Titan Ag 200 received FDA 510(k) clearance on 2018-08-09, under 510(k) number K173844.

Who is the listed applicant for Titan Ag 200?

The FDA 510(k) record lists Specialty Fibres and Materials, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Titan Ag 200?

The FDA product code for Titan Ag 200 is FRO. This falls under the Anesthesiology category.

Related Devices (Code: FRO)

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.

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, 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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