Granudacyn® Wound Irrigation Solution

K243415 · P.G.F. Industry Solutions GmbH · FRO · Jul 22, 2025 · SU

Device Facts

• Record ID: K243415
• Device Name: Granudacyn® Wound Irrigation Solution
• Applicant: P.G.F. Industry Solutions GmbH
• Product Code: FRO · SU
• Decision Date: Jul 22, 2025
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.

Device Story

Granudacyn Wound Wash Solution is a topical irrigation solution composed of water, sodium chloride, hypochlorous acid, and sodium hypochlorite. Produced via electrolysis, the solution is used for mechanical removal of wound debris, microorganisms, and foreign material from various acute and chronic dermal lesions. It is intended for use in both healthcare facilities and homecare settings under the supervision of healthcare professionals. The solution is applied via squeeze bottle, spray nozzle, or instillation bottle. By cleansing and moistening the wound bed, the device supports wound management and dressing maintenance. It is a non-sterile, single-patient, multi-use product.

Clinical Evidence

No clinical data was required to support substantial equivalence. Safety and effectiveness were demonstrated through non-clinical bench testing, including biocompatibility evaluation per ISO 10993-1 and antimicrobial effectiveness testing per USP <51>.

Technological Characteristics

Composition: Water, sodium chloride, hypochlorous acid, sodium hypochlorite. Mechanism: Mechanical removal of wound debris. Biocompatibility: ISO 10993-1. Antimicrobial effectiveness: USP <51>. Application: Squeeze bottle, spray nozzle, or instillation bottle. Shelf life: 28 months. Sterility: Non-sterile.

Indications for Use

Indicated for cleansing, irrigating, moistening, and debridement of exudating or dirty wounds, acute and chronic dermal lesions (e.g., pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, burns, abrasions, skin irritations, ingrown toe nails, grafted/donor sites, exit sites) and for moistening/lubricating absorbent wound dressings under healthcare professional supervision.

Predicate Devices

• Vashe® Wound Solution (K131848)

Reference Devices

• Microdacyn® Wound Care Solution (K233399)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

July 22, 2025

P.G.F. Industry Solutions GmbH
% Leonard Stewart
Regulatory Affairs Manager
Molnlycke Health Care US, LLC
5445 Triangle Parkway
Suite 400
Peachtree Corners, Georgia 30092

Re: K243415
Trade/Device Name: Granudacyn® Wound Irrigation Solution
Regulatory Class: Unclassified
Product Code: FRO
Dated: June 17, 2025
Received: June 17, 2025

Dear Leonard Stewart:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K243415 - Leonard Stewart
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K243415 - Leonard Stewart
Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mustafa A.
Mazher -S

For Yu-Chieh Chiu, PhD
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K243415

Device Name
Granudacyn® Wound Wash Solution

Indications for Use (Describe)
Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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K243415

# 510(k) SUMMARY

This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

Date Prepared: July 21, 2025

Applicant: Peter Fritz, CEO
P.G.F. Industry Solutions GmbH
Katzmoosstraße 26a
5161 Elixhausen, Austria
Phone: [phone]
Fax: [phone]
Email: [e-mail]

Official Correspondent: Leonard Stewart
Manager, Regulatory Affairs
Mölnlycke Health Care US, LLC
5445 Triangle Parkway, Suite 400
Peachtree Corners, GA 30092
Phone Number: 678-451-6072
Email: [e-mail]

Trade/Proprietary Names: Granudacyn® Wound Wash Solution

Device Class: Unclassified

Unclassified Reason: Pre-Amendment

Product Code: FRO

Predicate Device Name: Vashe® Wound Solution (K131848)
Reference Device Name: Microdacyn® Wound Care Solution (K233399)

## Device Description:

Granudacyn® Wound Wash Solution is composed of water (H2O), hypochlorous acid (HOCl), sodium hypochlorite (NaOCl) and sodium chloride (NaCl). Pure water and pure sodium chloride are subjected to an electrolysis process to create the final solution.

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K243415

# Intended Use/Indication for Use:

Under the supervision of healthcare professionals, Granudacyn Wound Wash Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings.

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K243415

Technological Characteristics:

| Feature | Granudacyn Wound Wash Solution | Vashe Wound Solution | Substantial Equivalence Comments |
| --- | --- | --- | --- |
| 510(k) clearance | K243415 | K131848 | NA |
| Rationale for inclusion | Subject of submission | Predicate device | NA |
| Manufacturer | P.G.F. Industry Solutions GmbH | Urgo Medical North America, LLC | NA |
| Device class name | Dressing, Wound, Drug | Dressing, Wound, Drug | Same classification as predicate |
| Class | Unclassified | Unclassified | Same classification as predicate |
| Product code | FRO | FRO | Same product code as predicate |
| Indication for use/Intended use | Under the supervision of healthcare professionals, Granudacyn Wound Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and/ or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings. | Under the supervision of healthcare professionals, Vashe Wound Solution is intended for cleansing, irrigating, moistening, debridement and removal of foreign material including microorganisms and debris from exudating and / or dirty wounds, acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted and donor sites, and exit sites. It is also intended for moistening and lubricating absorbent wound dressings. | Same |

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K243415

| Feature | Granudacyn Wound Wash Solution | Vashe Wound Solution | Substantial Equivalence Comments |
| --- | --- | --- | --- |
| Composition | Water, sodium chloride
Hypochlorous Acid,
Sodium Hypochlorite | Vashe(K131848):Water,
sodium chloride
Hypochlorous Acid | The difference between the predicate and the subject device does not impact substantial equivalence and is supported by Antimicrobial Effectiveness (USP<51>)testing |
| Use environment | Healthcare facilities and
homecare setting | Healthcare facilities and
homecare setting | Same |
| Use Case | Single patient, multi-use | Single patient, multi-use | Same |
| Mechanism(s)
of Action | mechanical removal of
wound debris | mechanical removal of
wound debris | Same |
| Antimicrobial Preservative | Preservative:
Hypochlorous acid,
Sodium Hypochlorite | Vashe(K131848)
Preservative:
Hypochlorous acid | The difference between the predicate and the subject device does not impact substantial equivalence and is supported by Antimicrobial Effectiveness (USP<51>)testing |
| Volume | 250ml, 500ml,1000ml | 118ml, 250ml, 473ml | Difference does not impact substantial equivalence |
| Application Method | Squeeze bottle, spray nozzle, instillation bottle offered | Squeeze bottle, spray nozzle, instillation bottle offered | Same |
| Shelf Life | 28 months | 24 months | Difference does not impact substantial equivalence and is supported by stability studies |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Biocompatibility | Biocompatible, Per ISO 10993-1 | Biocompatible, Per ISO 10993-1 | Same |
| Antimicrobial Effectiveness | Effective preservative for stated shelf life per, USP<51> | Effective preservative for stated shelf life per, USP<51> | Same |
| Clinical Data Summary – Subject Device | | | |
| Clinical Testing | Clinical data is not required. | | |

4

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K243415

## Non-Clinical Testing:

Testing was conducted to demonstrate the safety and the effectiveness of the subject device as well as the substantial equivalence to the predicate device:

- Biocompatibility – the subject device has been evaluated in accordance with ISO 10993-1 and has been shown to meet the criteria for the relevant endpoints, based on the chemical characterization, nature of body contact, and contact duration.
- Preservative Effectiveness – the subject device has been evaluated in accordance with USP &lt;51&gt; for preservative effectiveness and met the criteria aligned with its intended use.

## Clinical Data :

No clinical data was required to support substantial equivalence.

## Conclusion:

Substantial equivalence was demonstrated through a comparison of intended use, technological characteristics as well as performance and safety. Granudacyn Wound Wash is at least as safe and effective, and performs as well at the predicate device, Vashe Wound Solution.