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FDA 510(k)

GAUZE PACKING, SURGICAL STERILE AND NON-STERILE

K-Number: K913575 · 1991-09-06

ApplicantKeilei Intl., Inc.
Decision Date1991-09-06
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

GAUZE PACKING, SURGICAL STERILE AND NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Keilei Intl., Inc.. It received FDA 510(k) clearance on 1991-09-06 under 510(k) number K913575. 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 GAUZE PACKING, SURGICAL STERILE AND NON-STERILE?

GAUZE PACKING, SURGICAL STERILE AND NON-STERILE is a medical device that received FDA 510(k) clearance on 1991-09-06. The listed applicant is Keilei Intl., Inc.. The 510(k) number is K913575.

When did GAUZE PACKING, SURGICAL STERILE AND NON-STERILE receive FDA 510(k) clearance?

GAUZE PACKING, SURGICAL STERILE AND NON-STERILE received FDA 510(k) clearance on 1991-09-06, under 510(k) number K913575.

Who is the listed applicant for GAUZE PACKING, SURGICAL STERILE AND NON-STERILE?

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

What is the FDA product code for GAUZE PACKING, SURGICAL STERILE AND NON-STERILE?

The FDA product code for GAUZE PACKING, SURGICAL STERILE AND NON-STERILE is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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.

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Other records listing Keilei Intl., Inc. 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.

K913779BANDAGE ROLL, GAUZEK912779GAUZE SPONGE,STERILE 2'SK895372X-RAY DETECTABLE GAUZE SPONGEK895086GAUZE SPONGE

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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