Avance® 662000
Avance 662000 is a negative-pressure wound therapy system drape (FDA Class II; FDA product code OMP, negative pressure wound therapy Powered suction pump) made by Mölnlycke Health Care AB, cleared under FDA 510(k) K122132 on 17 Jan 2013 and listed in FDA GUDID since 27 Jan 2021 (UDI-DI 07332551876944), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07332551876944 | Date27 Jan 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK122132 | Date17 Jan 2013 | StatusActive |
Official records
- AccessGUDID record 07332551876944
- FDA 510(k) database K122132
Across registries
- FDA 510(k) K122132 decided 17 Jan 2013 Active
- FDA GUDID UDI-DI 07332551876944 listed 27 Jan 2021 Listed
Timeline
- Cleared FDA 510(k) K122132
- Listed FDA GUDID 07332551876944
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Avance®
- Generic name
- Negative-pressure wound therapy system drape
- Model / reference
- 662000
- Primary DI / UDI-DI
- 07332551876944
- 510(k) Number
- FDA product code
- OMP
- GMDN term
- Negative-pressure wound therapy system drape
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Size
- Width — 0.0 MillimeterHeight — 0.0 MillimeterLength — 0.0 Millimeter
Similar devices
Other devices filed under FDA product code OMP (negative pressure wound therapy Powered suction pump).
- VAC THERAPY SYSTEM, MODELS 340000, M8259999, 320000, M8259968 AND 320100 by KCI USA, INC.
- PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KIT by Kci USA, Inc. (Kinetic Concepts, Inc.)
- Cardinal Health NPWT PRO HC by Cardinalhealth
- UNO 10x20 Dressing Kit UNO-0408 by GENADYNE BIOTECHNOLOGIES INC.
- UNO 7 Therapy Kit 15x20 U-S1520-4 by GENADYNE BIOTECHNOLOGIES INC.
- Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set by Cardinalhealth
- V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... by Kci USA, Inc. (Kinetic Concepts, Inc.)
- UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT by Blue Ocean Medical Product, LLC
- ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNIT by KCI USA, INC.
- RENASYS-G Gauze Dressing Kits with Soft Port by Smith & Nephew, Inc.