IWD-Gel™
Device Facts
| Record ID | K254191 |
|---|---|
| Device Name | IWD-Gel™ |
| Applicant | InnovaCorium, Inc. |
| Product Code | FRO · SU |
| Decision Date | Apr 7, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
| Attributes | Therapeutic |
Indications for Use
Rx Indications for Use: The IWD-Gel™ gel is intended to cleanse and moisten the wound bed, providing a moist environment, and is indicated for light to moderately exudating wounds such as: • diabetic foot ulcers • leg ulcers (venous stasis ulcers) • arterial ulcers and leg ulcers of mixed etiology • pressure ulcers/sores (partial and full thickness) • 1st and 2nd-degree superficial partial thickness burns • donor sites, traumatic and surgical wounds OTC Indications for Use: The IWD-Gel™ gel is intended to cleanse and moisten the wound bed, and for the management of minor cuts, abrasions, minor lacerations, and minor burns.
Device Story
IWD-Gel™ is a golden brown, scented, semi-transparent, non-sterile, single-patient use hydrogel dressing. It contains surfactants to trap debris for removal during dressing changes and preservatives (PHMB, Quercus robur extract, Thyme oil) to stabilize the gel. Applied topically to the wound bed by clinicians or patients, the gel cleanses and maintains a moist environment to support wound healing. It is used for various chronic and acute wounds. The device is a passive dressing; it does not involve electronic processing, software, or active sensing.
Clinical Evidence
No clinical data. Safety and efficacy were established through non-clinical bench testing, including biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, implantation), shelf-life, and an animal wound healing study. Physical/chemical characterization included pH, viscosity, specific gravity, and loss on drying.
Technological Characteristics
Amorphous hydrogel dressing containing non-absorbable hydropolymer, surfactants (Decyl Glycoside, Poloxamer 188, Rhamnolipid, Sophorolipid), and preservatives (PHMB, Quercus robur extract, Thyme oil). Non-sterile, single-use. Complies with ISO 10993-1 for biocompatibility. Tested per USP <51>, <61>, <62>, <791>, <911>, <731>, and <841>.
Indications for Use
Indicated for patients with light to moderately exudating wounds including diabetic foot ulcers, venous stasis ulcers, arterial/mixed etiology leg ulcers, partial/full thickness pressure ulcers, 1st/2nd-degree superficial partial thickness burns, donor sites, and surgical/traumatic wounds. Also indicated for OTC management of minor cuts, abrasions, lacerations, and burns.
Predicate Devices
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 7, 2026
InnovaCorium, Inc.
Marcelo Buzzi
CEO
Uf Innovate
747 SW 2nd Ave., Suite 354
Gainesville, Florida 32601
Re: K254191
Trade/Device Name: IWD-Gel™
Regulatory Class: Unclassified
Product Code: FRO
Dated: February 27, 2026
Received: February 27, 2026
Dear Marcelo Buzzi:
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"
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K254191 - Marcelo Buzzi
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(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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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K254191 - Marcelo Buzzi
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MUSTAFA A. MAZHER
-S
For Yu-Chieh Chiu, Ph.D.
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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FORM FDA 3881 (8/23)
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PSC Publishing Services (301) 443-6740
EF
| 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. |
| --- | --- |
| 510(k) Number (if known) K254191 | |
| Device Name IWD-Gel™ | |
| Indications for Use (Describe) | |
| Rx Indications for Use: The IWD-Gel™ gel is intended to cleanse and moisten the wound bed, providing a moist environment, and is indicated for light to moderately exudating wounds such as: • diabetic foot ulcers • leg ulcers (venous stasis ulcers) • arterial ulcers and leg ulcers of mixed etiology • pressure ulcers/sores (partial and full thickness) • 1st and 2nd-degree superficial partial thickness burns • donor sites, traumatic and surgical wounds | |
| OTC Indications for Use: The IWD-Gel™ gel is intended to cleanse and moisten the wound bed, and for the management of minor cuts, abrasions, minor lacerations, and minor burns. | |
| 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. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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K254191
# 510(k) Summary
## DATE PREPARED
April 6, 2026
## MANUFACTURER AND 510(k) OWNER
innovaCorium, Inc.
UF Innovate
747 SW 2nd Avenue, Suite 354
Gainesville, FL 32601
## OFFICIAL CONTACT
Marcelo Buzzi, CEO
Telephone: +1-352-745-5107
Email: marcelo.buzzi@innovacorium.com
## DEVICE INFORMATION
Proprietary Name/Trade Name: IWD-Gel™
Common Name: Dressing Wound, Drug
Regulation Number: N/A
Class: Unclassified
Product Code: FRO
Review Panel: General and Plastic Surgery
## PREDICATE DEVICE IDENTIFICATION
The IWD-Gel™ is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
| --- | --- | --- |
| K173911 | Medline Burn and Wound Gel (PluroGel®) / Medline Industries, Inc. | ✓ |
| K092086 | Amerigel® Wound Dressing Plus/ Amerx Health Care Corporation | |
The predicate devices have not been subject to a design related recall.
## DEVICE DESCRIPTION
The innovaCorium wound dressing (IWD-Gel™) is a golden brown, scented, semi-transparent gel intended to cleanse and moisten the wound bed. The IWD-Gel™ is made with a non-absorbable hydropolymer, natural surfactants, and preservatives and it helps create and maintain a moist environment.
The IWD-Gel™ is provided non-sterile for single-patient use. It contains a low concentration of surfactants, which trap debris for subsequent removal and rinse off at dressing change, and a preservative with Polyhexamethylene Biguanide (PHMB) and natural components, including Quercus robur Extract and Thyme oil, to stabilize the device during storage and extend shelf life.
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K254191
The IWD-Gel™ was developed for the management of wounds that benefit from a moist wound environment and cleansing. The proprietary formulation includes preservatives to inhibit the growth of microorganisms in the hydrogel within the container, cleansers (surfactants/dispersants), gelling agents (thickeners), and a moisturizer.
## INDICATIONS FOR USE
**Rx Indications for Use:** The IWD-Gel™ gel is intended to cleanse and moisten the wound bed, providing a moist environment, and is indicated for light to moderately exudating wounds such as:
- diabetic foot ulcers
- leg ulcers (venous stasis ulcers)
- arterial ulcers and leg ulcers of mixed etiology
- pressure ulcers/sores (partial and full thickness)
- 1st and 2nd-degree superficial partial thickness burns
- donor sites, traumatic and surgical wounds
**OTC Indications for Use:** The IWD-Gel™ gel is intended to cleanse and moisten the wound bed, and for the management of minor cuts, abrasion, minor laceration, and minor burns.
## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
innovaCorium believes that the IWD-Gel™ is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design and dimensions and uses similar materials as the Plurogel® (Medline Burn and Wound Dressing) (K173911) and Amerigel® (K092086) devices. The subject device has the same intended use and similar technological characteristics as the devices cleared in K173911 and K092086.
The operational characteristics of the proposed IWD-Gel™ are identical to the predicate devices in that they are intended to be used as primary or secondary coverings for the management of a variety of wounds. They provide a moist wound environment conducive to wound healing. The
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K254191
technological characteristics of the proposed IWD-Gel™ and the predicate devices are identical in that they are dressings that include a moist gel-like component and are suitable for the management of a variety of wounds.
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K254191
| | Subject Device | Primary Predicate Device | Secondary Predicate Device |
| --- | --- | --- | --- |
| | IWD-Gel™
innovaCorium | Medline Burn and Wound Gel
Medline
K173911 | AmeriGel® Wound Dressing Plus
Amerx Health Corporation
K092086 |
| Product Code | FRO | FRO | FRO |
| Regulation Number | N/A | N/A | N/A |
| Intended Use | Rx Use: The IWD-Gel™ is intended to cleanse and moisten the wound bed, providing a moist environment, and is indicated for light to moderately exudating wounds, such as:
• diabetic foot ulcers
• leg ulcers (venous stasis ulcers)
• arterial ulcers and leg ulcers of mixed etiology
• pressure ulcers/sores (partial and full thickness)
• 1st and 2nd degree superficial partial thickness burns
• donor sites, traumatic and surgical wounds.
OTC Use: The IWD-Gel™ gel is intended to cleanse and moisten the wound bed, and for the management of minor cuts, abrasion, minor laceration, and minor burns. | Medline Burn and Wound Dressing is intended to cleanse and moisten the wound bed for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial and full thickness wounds and surgical incisions. It can be used to provide a moist environment that supports autolytic debridement of necrotic tissue. | Indications for Use:
• Stage I - IV Pressure ulcers
• Venous stasis ulcers.
• Ulcerations caused by mixed vascular etiologies
• Diabetic skin ulcers
• First and second degree burns
• Post-surgical incisions
• Cuts and abrasions |
| Configuration | 1 oz tube
2 oz. tube
4 oz. tube | 1.75 oz. tube | 1 oz. tube
3 oz. tube |
| Design Features | Clear to translucent, water-soluble, virtually odorless amorphous wound gel with a surfactant and PHMB as a preservative. | Clear to translucent, water-soluble, virtually odorless amorphous wound gel with a surfactant and PHMB as a preservative. | Clear to translucent, water-soluble, virtually odorless amorphous wound gel with a surfactant and PEG as a preservative. |
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K254191
| Materials | • *Quercus robur* (Oak) Bark Extract
• Thyme Oil
• PHMB
• Decyl Glycoside (polyglycoside)
• Poloxamer 188
• Rhamnolipid
• Sophorolipid
• Hyaluronic Acid
• Hydroxyethylcellulose
• Polyethylene Glycol 400
• Phenoxyethanol
• Water | • PHMB
• Glycerin
• Poloxamer
• Sucrose
• Sodium Phosphate Dibasic
• Citric Acid
• Water | • Oakinn (oak extract)
• Meadowsweet extract
• Polyethylene glycol (PEG)
• Zinc acetate
• Lidocaine HCl
• Water |
| --- | --- | --- | --- |
| Non-clinical testing | • Biocompatibility, in accordance with ISO 10993-1 (breached or compromised surfaces with prolonged contact (>24h to30d)
• Shelf-life
• USP <51>
• USP<61> Microbial Limits
• USP <62> Microbiological Examination on Non-Sterile Products
• Wound Healing Study
• pH
• Viscosity
• Specific gravity
• Loss on drying | • Biocompatibility, in accordance with ISO 10993-1 (breached or compromised surfaces with prolonged contact (>24h to30d)
• Shelf-life
• USP <51> Antimicrobial Effectiveness
• USP<61> Microbial Limits
• USP <62> Microbiological Examination on Non-Sterile Products
• Wound Healing Study | • Biocompatibility, in accordance with ISO 10993-1 (breached or compromised surfaces with prolonged contact (>24h to30)
Biocompatibility, in accordance with ISO 10993-1 (breached or compromised surfaces with prolonged contact (>24h to30d) |
| Sterile vs. Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Reusable vs. Single use | Single use | Single use | Single use |
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K254191
# SUMMARY OF NON-CLINICAL TESTING
The following tests were performed to demonstrate safety based on current industry standards:
- pH (USP <791>)
- Viscosity (USP <911>)
- Loss on Drying (USP <731>)
- Specific Gravity (<USP 841>)
- Biocompatibility (ISO 10993-1)
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Subacute/Subchronic Toxicity
- Implantation
- USP <51>
- Shelf-Life
- Non-clinical performance (animal wound healing study)
# SUMMARY OF CLINICAL TESTING
Clinical testing was not required.
# CONCLUSION
The IWD-Gel™ is considered substantially equivalent to the predicate devices based on the testing performed, the identical indications for use, and similar technological characteristics. Based on the testing performed, including biocompatibility and the non-clinical animal study, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices.
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