510(k) K082750
K082750 is an FDA 510(k) premarket notification submitted by Entrigue Surgical, Inc. for the device "ENTACT SEPTAL STAPLER, MODEL 610-00100". The FDA issued a decision of Substantially Equivalent on January 6, 2009. The device falls under product code OLL (Septal Stapler/Absorbable Staples), a Class II device regulated under 21 CFR 878.4750. Entrigue Surgical, Inc. has at least 3 other 510(k) clearances on record.
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.