OLL — Septal Stapler/Absorbable Staples Class II
FDA product code OLL covers "Septal Stapler/Absorbable Staples", a Class II medical device regulated under 21 CFR 878.4750. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OLL
- Device Class
- Class II
- Regulation Number
- 878.4750
- Submission Type
- Review Panel
- EN
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K082750 | entrigue surgical | ENTACT SEPTAL STAPLER, MODEL 610-00100 | January 6, 2009 |