OOD — Surgical Film Class II
FDA product code OOD covers "Surgical Film", a Class II medical device regulated under 21 CFR 878.3300. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OOD
- Device Class
- Class II
- Regulation Number
- 878.3300
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
To be implanted to reinforce soft tissue or bone where weakness exists. Intended to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological, or gastrointestinal anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The absorbable protective film also may help minimize the potential for tissue attachment to the device in case of direct contact with the viscera.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233999 | tepha | GalaFLEX LITE Scaffold | April 9, 2024 |
| K202425 | tepha | SurgiLattice scaffold | August 19, 2021 |
| K162922 | tepha | GalaFORM 3D | February 23, 2017 |
| K161424 | c.r. bard | Phasix Mesh | September 29, 2016 |
| K161092 | tepha | GalaSHAPE 3D | August 23, 2016 |
| K142818 | c. r. bard | Phasix Mesh | March 31, 2015 |
| K140533 | tepha | GALAFLEX MESH | May 21, 2014 |
| K130326 | tepha | TEPHAFLEX MELTBLOWN CONSTRUCT | May 7, 2013 |
| K113721 | tepha | TEPHAFLEX LIGHT MESH | February 15, 2012 |
| K113723 | tepha | TEPHAFLEX MESH | February 15, 2012 |
| K111946 | tepha | TEPHAFLEX MESH | September 26, 2011 |
| K091633 | tepha | TEPHAFLEX SURGICAL FILM | August 7, 2009 |
| K070894 | tepha | TEPHAFLEX SURGICAL MESH | April 13, 2007 |