Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film Avance Foam
FDA 510(k) K122132 · Molnlycke Health Care
Submission
- Device name
- Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film Avance Foam
- Applicant
- Molnlycke Health Care
Norcross, GA, US - Received
- July 18, 2012
- Decision date
- January 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
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|---|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741)OMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2026SE |
| K253263 | ConvaVAC Negative Pressure Wound Therapy SystemOMP · Traditional | Convatec Limited, Gdc Building | 06/24/2026SE |
| K253199 | Curasys 2 (EMDN0003)OMP · Traditional | CG Bio Co., Ltd. | 06/23/2026SE |
| K260646 | Renasys Edge (66803126)OMP · Traditional | Smith & Nephew Medical, Ltd. | 05/27/2026SE |
| K261291 | Nisus NPWT Canister 500-mL (CPC-500)OMP · Special | Cork Medical | 05/21/2026SE |
| K254019 | Wound Geni NPWT SystemOMP · Traditional | Bechtel Medical, Inc. | 05/04/2026SE |
| K253429 | Genadyne ASTRA NPWTOMP · Traditional | Genadyne Biotechnologies, Inc. | 03/12/2026SE |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…OMP · Traditional | Deroyal Industries, Inc. | 11/21/2025SE |
| K251646 | extriCARE® 1000 Negative Pressure Wound Therapy SystemOMP · Traditional | Alleva Medical Devices | 10/03/2025SE |
| K251826 | RENASYS WOUND+ Dressing Kit with AIRLOCK TechnologyOMP · Traditional | Smith & Nephew Medical, Ltd. | 09/11/2025SE |
More from Smith & Nephew Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K130852 | Avance® Foam Abdominal Dressing KitOXJ · Traditional | 04/14/2014SE |
| K130040 | Mepitel AGFRO · Traditional | 02/12/2014SE |
| K123892 | Mepilex Transfer AGFRO · Traditional | 04/05/2013SE |
| K102923 | Barrier N95 Particulate RespiratorMSH · Abbreviated | 11/19/2010SE |
| K100029 | Mepilex Border AG DressingFRO · Traditional | 09/15/2010SE |
| K061554 | Mepilex AG Absorbent Silicone-Coated DressingFRO · Traditional | 01/25/2007SE |
| K062138 | Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free Polychloroprene…LZA · Special | 10/05/2006SE |
| K051625 | Barrier Surgical DrapesKKX · Special | 07/14/2005SE |
| K050786 | Barrier Surgical GownsFYA · Special | 05/09/2005SE |
| K031131 | Klinidrape Surgical DrapesKKX · Traditional | 06/10/2003SE |
Questions and answers
When was Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film Avance Foam cleared by the FDA?
Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large) Avance Transparent Film Avance Foam (K122132) received a 510(k) decision of Substantially Equivalent on January 17, 2013, 183 days after the submission was received.
What is the product code of K122132?
The FDA product code is OMP – Negative Pressure Wound Therapy Powered Suction Pump, a Class II (moderate risk) device regulated under 21 CFR 878.4780.