ExtriCARE ST396-0001
ExtriCARE ST396-0001 (EC-FOAM-S-E) is a medical device (FDA Class II; FDA product code OMP, Negative Pressure Wound Therapy Powered Suction Pump) made by Alleva Medical Limited, cleared under FDA 510(k) K140634 on 19 Sep 2014 and listed in FDA GUDID since 12 Dec 2023 (UDI-DI 04897089070149), active as of 12 Nov 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 | Number04897089070149 | Date12 Dec 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK140634 | Date19 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 04897089070149
- FDA 510(k) database K140634
Across registries
- FDA 510(k) K140634 decided 19 Sep 2014 Active
- FDA GUDID UDI-DI 04897089070149 listed 12 Dec 2023 Listed
Timeline
- Cleared FDA 510(k) K140634
- Listed FDA GUDID 04897089070149
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ExtriCARE
- Generic name
- Negative-pressure wound therapy system foam dressing, non-antimicrobial
- Model / Ref / Catalog
- ST396-0001, EC-FOAM-S-E
- Primary DI / UDI-DI
- 04897089070149
- 510(k) Number
- FDA product code
- OMP
- GMDN term
- Negative-pressure wound therapy system foam dressing, non-antimicrobial
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Ethylene Oxide
Similar devices in this category
Other devices filed under Negative-pressure wound therapy system foam dressing, non-antimicrobial.
- Advazorb Silfix CR4178 by BRIGHTWAKE LIMITED
- Advazorb Border CR4486 by BRIGHTWAKE LIMITED
- UNO 10x40 Dressing Kit UNO-0416 by GENADYNE BIOTECHNOLOGIES INC.
- AMS Sterilization SMS Sheet 90cm*90cm AMS-90 by ADVANCED MEDICAL SOLUTIONS COMPANY
- Foam Medium XF-MFOAM2 by GENADYNE BIOTECHNOLOGIES INC.
- Avance® Solo 882000 by Mölnlycke Health Care AB
- RenoFoam F FF14EN23 by T&L Co.,Ltd.
- Fitostimoline spray MDR/04 by Farmaceutici Damor S.p.A.
- UCGel™ Debridement 15ml, 20 units 95180 by WELCARE INDUSTRIES S.p.A.
- proctoLYSYAL® 0SLD700C2G by SILDEHA Pharma Srl