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510(k) Data Aggregation
K Number
K243415Device Name
Granudacyn® Wound Irrigation Solution
Manufacturer
P.G.F. Industry Solutions GmbH
Date Cleared
2025-07-22
(263 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Product Code :
FRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K251093Device Name
Bonvadis®
Manufacturer
Oneness Biotech Co., Ltd.
Date Cleared
2025-06-09
(60 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Product Code :
FRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the direction of a healthcare professional, the Rx product is indicated for the management of partial and full thickness wounds, post-surgical wounds, 1st and superficial 2nd degree burns, diabetic foot ulcers, venous stasis ulcers, and pressure ulcers.
Device Description
Bonvadis® is a non-sterile water based, preserved, semi-viscous formulation, for prescription use. Bonvadis® contains methyl and propyl parabens which act as preservatives to inhibit the growth of microorganisms within the product before opening and between uses.
Bonvadis® is multiple use and supplied in a 15 g aluminum tube.
The formulation is to maintain a moist wound environment, the moist wound environment being conducive for wound healing.
Ingredients: Purified water, liquid petrolatum, white petrolatum, propylene glycol, cetyl stearyl alcohol, span 60, tween 60, Centella Asiatica extract, Mexican Mint extract, Methyl Paraben, and Propyl Paraben.
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K Number
K243457Device Name
Nixall Antimicrobial Solutions Skin & Wound Hydrogel
Manufacturer
Seriously Clean, Ltd
Date Cleared
2025-05-02
(176 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Product Code :
FRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is intended to be used for Over-The-Counter and Prescription Use. The Over-The-Counter use is intended for the following indications:
- For use on minor skin irritations, minor cuts, exit sites, minor lacerations, minor abrasions and minor burns, including sunburns.
- To moisten and lubricate absorbent wound dressings and moisten the wound bed. A moist wound and skin environment facilitates autolytic debridement.
The Prescription Use Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is indicated for the following uses:
- Use with dermal irritation, sores, injuries and ulcers of dermal tissues.
- Moistening and lubricating absorbent wound dressings and the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions.
- Management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I – IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
Device Description
The Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel is a hypochlorous acid hydrogel solution applied topically to skin and wound areas.
The hydrogel dressing is supplied in various packaging configurations. The OTC hydrogel and the prescription use hydrogel contain hypochlorous acid, a known antimicrobial, which serves as a preservative to inhibit the growth of microorganisms in the hydrogel during shelf-life. The OTC and RX products are supplied non-sterile.
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K Number
K243875Device Name
Spectricept Skin and Wound Cleanser
Manufacturer
Spectrum Antimicrobials, Inc.
Date Cleared
2025-04-21
(125 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Product Code :
FRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
**Spectricept Skin and Wound Cleanser for Professional Use:**
Under the supervision of a healthcare professional, Spectricept Skin and Wound Cleanser is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from wounds, and dermal lesions including stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, superficial second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites.
**Spectricept Skin and Wound Cleanser for OTC Use:**
Spectricept Skin and Wound Cleanser is intended for OTC use for cleansing, irrigating, moistening, debridement and removal of foreign material including debris from of skin abrasions, lacerations, minor irritations, cuts and intact skin.
Device Description
Spectricept Skin and Wound Cleanser is a clear hypotonic solution that aids in the removal of debris and foreign material from the application site. Foreign material and debris are mechanically removed by the action of the wound cleanser moving across the wound bed with or without the assistance of a suitable wound dressing (e.g., gauze).
Spectricept Skin and Wound Cleanser is a combination device that contains water (99.94%), hypochlorous acid, (0.036%), copper chloride (0.008%), zinc chloride (0.008%) and ferric chloride (0.008%). Hypochlorous acid functions as a preservative while the three inactive chloride salts function to assist in stabilizing hypochlorous acid in the bottle in the event that the solution is contaminated with inanimate during the device handling, operation of the spray nozzle and re-use.
Spectricept Skin and Wound Cleanser is a non-sterile aqueous solution in a 8oz PET bottle.
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K Number
K242406Device Name
SiOxC Cream
Manufacturer
SiOxMed, LLC
Date Cleared
2025-03-13
(211 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Product Code :
FRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SiOxC Cream is a skin emulsion indicated for management of dry intact skin by maintaining a moist skin environment. Not to be used on Breached or Compromised skin or open sores.
Device Description
SiOxC Cream is a fragrance free, preservative protected, non-sterile, topical cream intended for management of dry skin. SiOxC Cream supports a moist environment. SiOxC Cream is provided prescription only in various sizes for single patient use.
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K Number
K243001Device Name
Sterile Water USP and Sterile 0.9% Normal Saline USP
Manufacturer
Laboratorios Biogalenic S.A. DE C.V,
Date Cleared
2025-03-06
(161 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Product Code :
FRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Over-the-Counter Use: For moistening absorbent wound dreaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin. Prescription Use: For moistening absorbent wound dressing and for moistening, debriding, and cleaning acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.
Device Description
The subject device Sterile Water USP, and Sterile 0.9% Normal Saline USP is a colorless, transparent solution with no preservatives or antimicrobial agents added. It is used only for external irrigation, and not for injection purposes and it is a single use device. The subject device is packaged in clear, polypropylene (PP) bottles capped with PP Screw cap and filled with a sterile, preservative-free, clear, colorless aqueous solution and sealed with a PP/PET aluminum induction seal. The aqueous solution composition is either sterile 0.9% normal saline, both which meet their respective USP monograph criteria and contain no additives. The container and closure system for the 250mL, and 1000mL sizes include PP bottles with a PP screw cap with a PP/PET aluminum induction seal and a tamper evident plastic shrink wrap. The container and closure system for the 100mL size includes a PP bottle with a PP screw cap and a PP/PET aluminum induction seal. These single-use devices are labeled for device irrigation and wound debridement and are not intended for injection. The subject device will function by the mechanical action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.
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K Number
K240809Device Name
LUOFUCON® Silver Collagen Dressing
Manufacturer
Huizhou Foryou Medical Devices Co., Ltd.
Date Cleared
2024-12-16
(266 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Product Code :
FRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUOFUCON® Silver Collagen Dressing is intended for the management of wounds that include: Full thickness and partial thickness wounds Pressure ulcers venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers First and second degree burns Donor sites and other bleeding surface wounds Abrasions Trauma wounds healing by secondary intention Dehisced wounds Surgical wounds Dehisced surgical wounds
Device Description
LUOFUCON® Silver Collagen Dressing is comprised of bovine collagen and silver chloride intended for the management of wounds. Silver chloride is present to prevent bacteria colonization within the dressing. An in-vitro antibacterial effectiveness test showed that the dressing is effective against bacteria. LUOFUCON® Silver Collagen Dressing is a sterile, single use, pliable, absorbent and biodegradable wound dressing. In the present of the wound exudate LUOFUCON® Silver Collagen Dressing transforms into a soft, conformable gel sheet, maintains a physically moist environment, to protect the wound and support natural healing. LUOFUCON® Silver Collagen Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings.
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K Number
K242758Device Name
Atrauman® Ag
Manufacturer
Hartmann USA, Inc.
Date Cleared
2024-12-09
(88 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Product Code :
FRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Atrauman® Ag antimicrobial wound dressing is indicated for use with moderately exuding wounds such as pressure wounds, venous leg ulcers, diabetic ulcers, partial thickness burns, Skin graft donor sites, surgical wounds, and abrasions.
Device Description
Atrauman® Ag antibacterial solid wound dressing is a non-adherent silver impregnated antibacterial dressing that provides a moist wound environment. The dressing is composed of a meshed hydrophobic polyamide textile coated with metallic silver (2.1 mg/sq inch) that kills bacteria within the dressing and a hydrophilic matrix consisting mainly of triglycerides. The mesh fabric allows silver ion formation on its surface upon contact with exudate. The wound dressing is non-adhesive for dressing changes and can be cut-to-size.
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K Number
K242856Device Name
LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
Manufacturer
Huizhou Foryou Medical Devices Co., Ltd.
Date Cleared
2024-11-13
(54 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Product Code :
FRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Prescription Use:
LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to fullthickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.
OTC Use:
LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor scrapes, minor scalds and minor burns.
Device Description
LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.
- (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
- (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.
Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.
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K Number
K240510Device Name
Microdacyn Hydrogel
Manufacturer
Sonoma Pharmaceuticals, Inc.
Date Cleared
2024-11-08
(260 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Product Code :
FRO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx INDICATIONS: Under the supervision of a healthcare professional, Microdacyn Hydrogel is intended for management of wounds associated with dermal irritation, sores, injuries and ulcers of dermal tissue. Microdacyn Hydrogel is intended for use on first and second degree burns, exuding wounds such as leg ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
OTC INDICATIONS: Microdacyn Hydrogel is intended for use on minor skin irritations, lacerations, abrasions and minor burns. Microdacyn Hydrogel is also indicated for the management of irritation from minor sunburn.
Device Description
Microdacyn Hydrogel is a non-sterile, aqueous hydrogel that contains sodium hypochlorite and hypochlorous acid as preservatives to prevent the growth of microorganisms within the container during shelf-life.
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