FDA product code OQL: Mesh, Surgical, Deployment Balloon
OQL is the FDA product code for mesh, surgical, deployment balloon. 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 OQL. The average 510(k) review took 193 days (median 193).
Definition
The device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of hernias.
Classification
| Field | Value |
|---|---|
| Device name | Mesh, Surgical, Deployment Balloon |
| 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) |
Compare with all 510(k) review times · Search every OQL clearance
Top OQL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Surgical Structures , Ltd. | 1 | 2010-03-15 |
Most recent OQL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K092726 | Surgical Structures , Ltd. | MESH GPS - LARGE, SMALL, SM, SM SMALL | 2010-03-15 | 193 |
Recalls for OQL devices
openFDA lists no recalls for product code OQL.
Frequently asked questions
What is FDA product code OQL?
OQL is the FDA product code for mesh, surgical, deployment balloon. 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 OQL?
Class II, regulation 21 CFR 878.3300. Typical premarket route: 510(k).
How long does a 510(k) take for product code OQL?
Across 1 cleared submissions the average was 193 days from receipt to decision (median 193).
Which companies have the most OQL clearances?
Surgical Structures , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OQL
- Run a recall and safety report across every OQL manufacturer
- Watch product code OQL 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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