Avance Foam Dressing Kits
FDA 510(k) K141847 · Molnlycke Health Care Us, LLC
510(k) numberK141847
Submission
- Device name
- Avance Foam Dressing Kits
- Applicant
- Molnlycke Health Care Us, LLC
Norcross, GA, US - Received
- July 9, 2014
- Decision date
- March 26, 2015
- 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.
Other 510(k)s with product code OMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K232508 | Barrier EasyWarm Active Self-Warming BlanketDWJ · Special | 09/15/2023SE |
| K203369 | Avance Solo Negative Pressure Wound Therapy (NPWT) SystemOMP · Traditional | 07/01/2021SE |
| K202090 | Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator…KGO · Traditional | 11/22/2020SE |
| K193573 | Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator…KGO · Traditional | 04/10/2020SE |
| K191869 | Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim…KGO · Traditional | 03/13/2020SE |
| K190077 | Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator UndergloveKGO · Traditional | 05/24/2019SE |
| K161939 | Avance Abdominal Dressing KitOXJ · Traditional | 11/17/2016SE |
| K161935 | Avance Foam Dressing Kit - XLOMP · Traditional | 11/04/2016SE |
| K161948 | Avance Gauze Dressing KitsOMP · Traditional | 11/03/2016SE |
| K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPadOMP · Traditional | 10/19/2016SE |
Questions and answers
When was Avance Foam Dressing Kits cleared by the FDA?
Avance Foam Dressing Kits (K141847) received a 510(k) decision of Substantially Equivalent on March 26, 2015, 260 days after the submission was received.
What is the product code of K141847?
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.