Spiro Foam Dressing Kit
The Genadyne Spiro Foam Dressing Kit is used with the Genadyne A4-XLR8 Wound Vacuum System to deliver negative pressure wound therapy. Its intended wound types include pressure, diabetic or…
The Genadyne Spiro Foam Dressing Kit is used with the Genadyne A4-XLR8 Wound Vacuum System to deliver negative pressure wound therapy. Its intended wound types include pressure, diabetic or neuropathic and venous insufficiency ulcers, traumatic wounds, postoperative or dehisced surgical wounds, and skin flaps or grafts.
The dressing uses flexible polyether and polyester polyurethane foam with silicone tubing and transparent polyurethane film. Connected to the compatible vacuum system, the dressing supports removal of excess wound fluid, infectious material and tissue debris by suction.
Listed Item
The Genadyne Spiro Foam Dressing Kit consists of a XLR8 Port, two XLR8 Transparent Film and a two Spiro Foam Dressing. Each component is packaged, sealed and sterilized individually and then bagged into a kit.
Dressing Format
The Spiro foam has an uncoiled length of approximately 104 centimetres, a width of 1.9 centimetres and a height of 1.6 centimetres. The dressing is sterile and intended for single use.
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Shanghai ISO Medical Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Devon Medical Products (Jiangsu) Ltd | Nantong | Jiangsu | Repacker / relabeller | 12 |
| Nantong MedTech Medical Products Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
| Lightstone Medical Products (Ningbo) Co Ltd | Ningbo | Zhejiang | Specification developer | 3 |
Record
| Listed by | Genadyne Biotechnologies, Inc., United States |
|---|---|
| FDA product code | OMP |
| Device type | Negative Pressure Wound Therapy Powered Suction Pump |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K141961 |
| Record published | 2016-09-24 |
| Record revised | 2020-06-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XF-SPMK1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 57 |
| Pico | Smith & Nephew, Inc. | 57 |
| Negative Pressure Wound Therapy Powered Suction Pump | Carilex Medical, Inc. | 43 |
| DeRoyal | Deroyal Industries, Inc. | 34 |
| extriCARE | Oakwell Distribution, Inc. | 32 |
| Renasys | Smith & Nephew, Inc. | 27 |
| MicroDoc Npwt System | Pensar Medical | 26 |
| ExtriCARE | Alleva Medical Ltd | 22 |
| Vcare Alpha | I.V.T. Medical Ltd | 19 |
| V.A.C.® Granufoam™ | KCI USA, Inc. | 19 |
| Avance | Mölnlycke Health Care AB | 18 |
| Avance® Solo | Mölnlycke Health Care AB | 17 |
Showing 12 of 284. All products under Negative Pressure Wound Therapy Powered Suction Pump
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253429 | 2026-03-12 |
| K233614 | 2024-12-23 |
| K221888 | 2023-06-12 |
| K221891 | 2022-12-14 |
| K210107 | 2022-06-01 |
| K190028 | 2020-01-15 |
| K182722 | 2019-09-27 |
| K180840 | 2018-11-30 |
| K161599 | 2017-04-06 |
| K143726 | 2015-06-19 |
| K142646 | 2015-04-30 |
| K141961 | 2015-03-26 |
| K141437 | 2014-09-19 |
| K092992 | 2010-06-29 |
| K090638 | 2009-04-29 |
| K082676 | 2008-12-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.