510(k) K142818
- Device
- Phasix Mesh
- Applicant
- C.R. Bard
- 510(k) number
- K142818
- Product code
- OOD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-03-31
- Date received
- 2014-09-29
- Regulation
- 878.3300
- Classification name
- Surgical Film
- 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
- Steve Keenan
- Address
- 100 Crossings Blvd. Warwick RI US 02886 02886
FDA Registration Numbers#
- 3009337401
- 3005636544
- 3009514842
- 3021595883
- 1213643
- 3005670760
- 3006082230
- 3006174295
- 9615742
- 1223089
- 3010187263
- 3010383847
Source Documents#
Other 510(k) Records For Product Code OOD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233999 | GalaFLEX LITE Scaffold | Tepha, Inc. | 2024-04-09 |
| K202425 | SurgiLattice scaffold | Tepha, Inc. | 2021-08-19 |
| K162922 | GalaFORM 3D | Tepha, Inc. | 2017-02-23 |
| K161424 | Phasix Mesh | C.R. Bard, Inc. | 2016-09-29 |
| K161092 | GalaSHAPE 3D | Tepha, Inc. | 2016-08-23 |
| K140533 | GALAFLEX MESH | Tepha, Inc. | 2014-05-21 |
| K130326 | TEPHAFLEX MELTBLOWN CONSTRUCT | Tepha, Inc. | 2013-05-07 |
| K113721 | TEPHAFLEX LIGHT MESH | Tepha, Inc. | 2012-02-15 |
| K113723 | TEPHAFLEX MESH | Tepha, Inc. | 2012-02-15 |
| K111946 | TEPHAFLEX MESH | Tepha, Inc. | 2011-09-26 |
| K091633 | TEPHAFLEX SURGICAL FILM | Tepha, Inc. | 2009-08-07 |
| K070894 | TEPHAFLEX SURGICAL MESH | Tepha, Inc. | 2007-04-13 |
Legacy Summary#
summary
FDA Review#
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