FDA product code OOD: Surgical Film
OOD is the FDA product code for surgical film. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 13 510(k) submissions under OOD, 1 in the last five years, from 3 different applicants. The average 510(k) review took 114 days (median 88); 113 days on average over the last three years. FDA has posted 1 recall for OOD devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Surgical Film |
| Device class | Class II |
| Regulation | 21 CFR 878.3300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for OOD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 128 |
| 2021 | 1 | 359 |
| 2024 | 1 | 113 |
Compare with all 510(k) review times · Search every OOD clearance
Top OOD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tepha, Inc. | 11 | 2024-04-09 |
| C.R. Bard, Inc. | 1 | 2016-09-29 |
| C. R. Bard | 1 | 2015-03-31 |
Most recent OOD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233999 | Tepha, Inc. | GalaFLEX LITE Scaffold | 2024-04-09 | 113 |
| K202425 | Tepha, Inc. | SurgiLattice scaffold | 2021-08-19 | 359 |
| K162922 | Tepha, Inc. | GalaFORM 3D | 2017-02-23 | 128 |
| K161424 | C.R. Bard, Inc. | Phasix Mesh | 2016-09-29 | 129 |
| K161092 | Tepha, Inc. | GalaSHAPE 3D | 2016-08-23 | 127 |
Recalls for OOD devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-11-21.
Frequently asked questions
What is FDA product code OOD?
OOD is the FDA product code for surgical film. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel.
What device class is OOD?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OOD?
Across 13 cleared submissions the average was 114 days from receipt to decision (median 88).
Which companies have the most OOD clearances?
Tepha, Inc. (11); C.R. Bard, Inc. (1); C. R. Bard (1).
Have OOD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-11-21.
Next steps
- Run an FDA pathway report with predicate devices for product code OOD
- Run a recall and safety report across every OOD manufacturer
- Watch product code OOD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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