510(k) K190185

Device: Phasix ST Mesh With Open Positioning System
Applicant: C.R. Bard, Inc.
510(k) number: K190185
Product code: OWT
Decision: Substantially Equivalent (SESE)
Decision date: 2019-06-12
Date received: 2019-02-01
Regulation: 878.3300
Classification name: Mesh, Surgical, Absorbable, Abdominal Hernia
Medical specialty: General & Plastic Surgery
Review panel: General & Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Shirin Mate
Address: 100 Crossings Blvd. Warwick RI US 02886 02886

FDA Registration Numbers#

3003910212
3009337401
3005636544
3009514842
1213643
3006082230
3006174295
1319639
9615742
1223089
3010187263
3010383847

Source Documents#

Other 510(k) Records For Product Code OWT #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K243241	Phasix ST Umbilical Hernia Patch	Davol, Inc., A Subsidiary of C.R. Bard, Inc.	2025-02-19
K233661	Transorb™ Self-Gripping Resorbable Mesh	Sofradim Production	2024-02-13
K191749	TIGR Matrix Surgical Mesh, TIGR Surgical Mesh	Novus Scientific AB	2020-03-26
K191773	GORE BIO-A Tissue Reinforcement	W. L. Gore & Associates, Inc.	2019-07-31
K173143	Phasix ST Mesh	C.R. Bard, Inc.	2018-04-25
K163005	TIGR Matrix Surgical Mesh	Novus Scientific AB	2017-07-27
K143380	Phasix ST Mesh	C.R. Bard, Inc.	2015-06-05
K120728	PHASIX PLUG AND PATCH	C.R. Bard, Inc.	2012-10-22
K101287	TEPHAFLEX COMPOSITE MESH	Tepha, Inc.	2010-08-30
K033671	GORE BIOABSORBABLE MESH	W. L. Gore & Associates, Inc.	2003-12-31

Legacy Summary#

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