Genadyne Spiro Foam Dressing Kit
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Spiro Foam Dressing EUDAMEDFDA UDI
- Generic Name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
- Device Name
- Green Spiro Foam Medium EUDAMEDGenadyne Spiro Foam Dressing is a fully reticulated hydrophobic polyurethane foam made with polyether resin to allow better hydrolytic stability. While under pressure, this design allows increased performance in moist environments. The Foam promotes perfusion and assist in tissue granulation. In addition, fraying is reduced, preventing stray pieces from being left in the wound bed. It is a non-invasive, non-implantable medical device. FDA UDI
- Model / Reference
- XF-SPMF1 EUDAMEDFDA UDI
- Description
- Genadyne Spiro Foam Dressing is a fully reticulated hydrophobic polyurethane foam made with polyether resin to allow better hydrolytic stability. While under pressure, this design allows increased performance in moist environments. The Foam promotes perfusion and assist in tissue granulation. In addition, fraying is reduced, preventing stray pieces from being left in the wound bed. It is a non-invasive, non-implantable medical device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849405031321 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849405031321 EUDAMED
- 510(k) Number
- FDA Product Code
- OMP FDA 510(k)FDA UDI
- EMDN Code
- M04040601 POLYURETHANE DRESSINGS, NON-COMBINED EUDAMED
- GMDN Term
- Negative-pressure wound therapy system foam dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4780 FDA 510(k)
- Regulation Number
- 878.4780 FDA 510(k)FDA UDI
- Market of Registration
- Türkiye EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
The Genadyne Spiro Foam Dressing Kit is a Negative Pressure Wound Therapy (NPWT) device, designed to promote wound healing through controlled suction. It consists of foam dressings that apply negative pressure to the wound bed, facilitating granulation tissue formation, reducing edema, and enhancing perfusion to support healing in chronic or acute wounds.
This kit is supplied as a single-use, non-sterile device intended for use in clinical settings such as hospitals, surgical centers, or outpatient care. It is regulated under FDA 510(k) clearance and the Medical Devices Directive (MDD), with a classification as a Class II device. The kit includes foam dressings of specified sizes, intended for application under negative pressure therapy systems, and is not intended for MRI use. No additional sterilization is required prior to use as it is non-sterile.
Frequently asked questions
What types of wounds is the Genadyne Spiro Foam Dressing Kit designed to treat, and how does it work?
The Genadyne Spiro Foam Dressing Kit is designed to promote wound healing in chronic or acute wounds by applying negative pressure therapy (NPWT). It works by using foam dressings that, when connected to a negative pressure system, draw fluid away from the wound bed, reduce edema, and enhance blood flow to the area. This environment supports granulation tissue formation, which is critical for healing difficult or slow-to-heal wounds.
Is the Genadyne Spiro Foam Dressing Kit sterile, and if not, what does that mean for clinical use?
No, the Genadyne Spiro Foam Dressing Kit is non-sterile and is intended for single-use in clinical settings. Since it is not sterile, it must be handled in a manner that minimizes contamination before application. Clinicians should follow standard aseptic techniques when preparing and applying the dressing to ensure a clean wound environment.
What sizes of foam dressings are included in the kit, and how are they selected for use?
The kit includes foam dressings of specified sizes, though the exact dimensions are not detailed in the provided data. Selection of the appropriate size depends on the wound’s dimensions and the clinical protocol for negative pressure therapy. The foam must be cut or shaped to fit the wound bed securely while ensuring proper sealing to maintain effective suction.
Can the Genadyne Spiro Foam Dressing Kit be used with any negative pressure wound therapy system, or are there compatibility requirements?
The kit is designed to be used under negative pressure therapy systems, but the data does not specify compatibility with all systems. Clinicians should verify compatibility with their chosen NPWT device to ensure proper function. The kit itself is not a standalone pump or suction source—it requires integration with an external NPWT system.
What regulatory pathways does the Genadyne Spiro Foam Dressing Kit follow, and what does that mean for purchasing or clinical adoption?
The kit is regulated under FDA 510(k) clearance and the Medical Devices Directive (MDD), classified as a Class II device. This means it has undergone a premarket review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and performance standards. For purchasing or adoption, this classification indicates it is subject to quality system regulations and must comply with manufacturing, labeling, and post-market surveillance requirements.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K141961 | Class II | Active |
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Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
Sources (3)
- FDA 510(k) K141961 24 fields · synced Sep 18, 2026
- FDA UDI 8ee2ab61-2a78-4294-ae63-b0171687f0bc 34 fields · synced May 30, 2026
- EUDAMED e06ff394-0ffd-44c3-94a2-df3020150316 61 fields · synced Jul 11, 2026