OLL — Septal Stapler/Absorbable Staples Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K082750entrigue surgicalENTACT SEPTAL STAPLER, MODEL 610-00100January 6, 2009