Septal Stapler/Absorbable Staples
The Septal Stapler/Absorbable Staples (product code OLL) is a Class 2 implantable device regulated under 21 CFR 878.4750 in the General, Plastic Surgery specialty (SU), cleared via 510(k). It is designed to approximate soft tissues using absorbable staples delivered via a pre-loaded stapler during nasal septal surgery, including procedures with or without cartilage reinsertion, to aid healing of the nasal septum. The device is flagged as an implant due to the absorbable staples placed within the nasal tissue, and it is not life-sustaining.
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Basic Information
- Product Code
- OLL
- Device Class
- FDA class 2
- Regulation Number
- 878.4750
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K082750 | ENTACT SEPTAL STAPLER, MODEL 610-00100 | Jan 06, 2009 | Substantially Equivalent | Entrigue Surgical, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.