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FDA 510(k)

PROSIT WOUND TREATMENT DEVICE

K-Number: K081977 · 2008-12-01

ApplicantSilverleaf Medical Products, Inc.
Decision Date2008-12-01
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

PROSIT WOUND TREATMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Silverleaf Medical Products, Inc.. It received FDA 510(k) clearance on 2008-12-01 under 510(k) number K081977. 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 PROSIT WOUND TREATMENT DEVICE?

PROSIT WOUND TREATMENT DEVICE is a medical device that received FDA 510(k) clearance on 2008-12-01. The listed applicant is Silverleaf Medical Products, Inc.. The 510(k) number is K081977.

When did PROSIT WOUND TREATMENT DEVICE receive FDA 510(k) clearance?

PROSIT WOUND TREATMENT DEVICE received FDA 510(k) clearance on 2008-12-01, under 510(k) number K081977.

Who is the listed applicant for PROSIT WOUND TREATMENT DEVICE?

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

What is the FDA product code for PROSIT WOUND TREATMENT DEVICE?

The FDA product code for PROSIT WOUND TREATMENT DEVICE 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 Silverleaf Medical Products, 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.

K060237CMB ANTIMICROBIAL DRESSING

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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