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FDA 510(k)

CORELEADER ALGIPLASTER MODEL AP 050501

K-Number: K102942 · 2011-06-22

ApplicantCoreleader Biotech Co., Ltd.
Decision Date2011-06-22
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

CORELEADER ALGIPLASTER MODEL AP 050501 is the device name listed in this FDA 510(k) record. The listed applicant is Coreleader Biotech Co., Ltd.. It received FDA 510(k) clearance on 2011-06-22 under 510(k) number K102942. 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 CORELEADER ALGIPLASTER MODEL AP 050501?

CORELEADER ALGIPLASTER MODEL AP 050501 is a medical device that received FDA 510(k) clearance on 2011-06-22. The listed applicant is Coreleader Biotech Co., Ltd.. The 510(k) number is K102942.

When did CORELEADER ALGIPLASTER MODEL AP 050501 receive FDA 510(k) clearance?

CORELEADER ALGIPLASTER MODEL AP 050501 received FDA 510(k) clearance on 2011-06-22, under 510(k) number K102942.

Who is the listed applicant for CORELEADER ALGIPLASTER MODEL AP 050501?

The FDA 510(k) record lists Coreleader Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORELEADER ALGIPLASTER MODEL AP 050501?

The FDA product code for CORELEADER ALGIPLASTER MODEL AP 050501 is FRO. This falls under the Anesthesiology category.

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Other records listing Coreleader Biotech Co., Ltd. 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.

K123394CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSINGK111578CORELEADER COLLA-ALGI FIBER MODEL CAWK111733CORELEADER SCAR-DIMMERK102944CORELEADER HEMO-PAD MODEL CPII 02030K102946CORELEADER COLLA-PAD MODEL CS 03030K102943CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050

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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

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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