The following data is part of a premarket notification filed by Medela Ag with the FDA for Invia Endure Negative Pressure Wound Therapy System.
| Device ID | K141926 |
| 510k Number | K141926 |
| Device Name: | INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | MEDELA AG W324S3649 COUNTY ROAD E Dousman, WI 53118 |
| Contact | Adrienne Lenz |
| Correspondent | Adrienne Lenz MEDELA AG W324S3649 COUNTY ROAD E Dousman, WI 53118 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-16 |
| Decision Date | 2014-12-19 |
| Summary: | summary |