Atlas FDA

MEDELA INVIA WOUND THERAPY

FDA 510(k) clearance K080357 · decided 2008-07-24

Clearance details

K-number
K080357
Device name
MEDELA INVIA WOUND THERAPY
Applicant
Medela AG
Decision
Substantially Equivalent
Date received
2008-02-11
Decision date
2008-07-24
Days to decision
164 days
Clearance type
Traditional
Product code
OMP
Device class
2
Regulation number
878.4780
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Baar Zug, CH
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare, Mc recall (Z-3172-2011)Medela Inc2011-09-08