510(k) K082750
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 6, 2009
- Date Received
- September 19, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Septal Stapler/Absorbable Staples
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- EN
- Submission Type
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.