FDA product code OWR: Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
OWR is the FDA product code for mesh, surgical, non-absorbable, facial implants for plastic surgery. It is a Class II device, regulated under 21 CFR 878.3300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under OWR, 1 in the last five years. The average 510(k) review took 1139 days (median 1139).
Definition
For reinforcement of soft tissue where weakness exists in facial plastic surgery.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery |
| 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 |
510(k) clearances per year for OWR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 1139 |
Compare with all 510(k) review times · Search every OWR clearance
Top OWR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Shanghai Suokang Medical Implants Co., Ltd. | 1 | 2023-06-13 |
Most recent OWR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201153 | Shanghai Suokang Medical Implants Co., Ltd. | Tisuthes e-PTFE Surgical Patch | 2023-06-13 | 1139 |
Recalls for OWR devices
openFDA lists no recalls for product code OWR.
Frequently asked questions
What is FDA product code OWR?
OWR is the FDA product code for mesh, surgical, non-absorbable, facial implants for plastic surgery. 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 OWR?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWR?
Across 1 cleared submissions the average was 1139 days from receipt to decision (median 1139).
Which companies have the most OWR clearances?
Shanghai Suokang Medical Implants Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OWR
- Run a recall and safety report across every OWR manufacturer
- Watch product code OWR 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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