Avance® Foam Abdominal Dressing Kit
FDA 510(k) K130852 · Molnlycke Health Care
510(k) numberK130852
Submission
- Device name
- Avance® Foam Abdominal Dressing Kit
- Applicant
- Molnlycke Health Care
Norcross, GA, US - Received
- March 28, 2013
- Decision date
- April 14, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OXJ – Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists in abdominal wall defects.
Other 510(k)s with product code OXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161939 | Avance Abdominal Dressing KitOXJ · Traditional | Molnlycke Health Care Us, LLC | 11/17/2016SE |
More from Molnlycke Health Care Us, LLC
| 510(k) | Device | Decision |
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| K130040 | Mepitel AGFRO · Traditional | 02/12/2014SE |
| K123892 | Mepilex Transfer AGFRO · Traditional | 04/05/2013SE |
| K122132 | Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)…OMP · Traditional | 01/17/2013SE |
| 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 Abdominal Dressing Kit cleared by the FDA?
Avance® Foam Abdominal Dressing Kit (K130852) received a 510(k) decision of Substantially Equivalent on April 14, 2014, 382 days after the submission was received.
What is the product code of K130852?
The FDA product code is OXJ – Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects, a Class II (moderate risk) device regulated under 21 CFR 878.3300.