510(k) clearances

Phasix ST Umbilical Hernia Patch

Davol, Inc., A Subsidiary of C.R. Bard, Inc. · General, Plastic Surgery

K243241Substantially EquivalentTraditionalOWT
Open FDA's page for this record
Third party flag
N
City
Warwick
Advisory committee description
General, Plastic Surgery
Address 1
100 Crossings Blvd.
Statement or summary
Summary
Product code
OWT
Zip code
02886
Applicant
Davol, Inc., A Subsidiary of C.R. Bard, Inc.
Decision date
2025-02-19
Decision code
SESE
Country code
US
Device name
Phasix ST Umbilical Hernia Patch
Advisory committee
SU
Contact
Shannon Green
K number
K243241
State
RI
Date received
2024-10-10
Review advisory committee
SU
Postal code
02886
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Mesh, Surgical, Absorbable, Abdominal Hernia
Medical specialty description
General, Plastic Surgery
Regulation number
878.3300
Device class
2
Registration number
9615742, 3010187263, 1213643, 3006082230, 3009514842, 3003910212, 3005636544, 3010383847, 1319639, 3009337401, 1223089, 3006174295
FEI number
3003521774, 3010187263, 1213643, 1000138054, 3009514842, 3003910212, 3005636544, 3010383847, 1000120505, 3006082230, 3009337401, 3006174295
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.