FDA product code OLL: Septal Stapler/Absorbable Staples
OLL is the FDA product code for septal stapler/absorbable staples. It is a Class II device, regulated under 21 CFR 878.4750 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1 510(k) submission under OLL. The average 510(k) review took 109 days (median 109).
Definition
To approximate soft tissues by means of absorbable staples delivered via a pre-loaded stapler delivery system for use during nasal septal surgery, with or without cartilage reinserted. To connect internal nasal tissues to aid healing during nasal septum reconstruction.
Classification
| Field | Value |
|---|---|
| Device name | Septal Stapler/Absorbable Staples |
| Device class | Class II |
| Regulation | 21 CFR 878.4750 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every OLL clearance
Top OLL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Entrigue Surgical, Inc. | 1 | 2009-01-06 |
Most recent OLL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K082750 | Entrigue Surgical, Inc. | ENTACT SEPTAL STAPLER, MODEL 610-00100 | 2009-01-06 | 109 |
Recalls for OLL devices
openFDA lists no recalls for product code OLL.
Frequently asked questions
What is FDA product code OLL?
OLL is the FDA product code for septal stapler/absorbable staples. It is a Class II device, regulated under 21 CFR 878.4750 and reviewed by the Ear, Nose and Throat panel.
What device class is OLL?
Class II, regulation 21 CFR 878.4750. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLL?
Across 1 cleared submissions the average was 109 days from receipt to decision (median 109).
Which companies have the most OLL clearances?
Entrigue Surgical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OLL
- Run a recall and safety report across every OLL manufacturer
- Watch product code OLL 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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