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U.S. Department of Health and Human Services

Product Classification

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Device septal stapler/absorbable staples
Regulation Description Implantable staple.
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.
Physical State Resorbable polymer (e.g., poly(L-lactide-co-glycolide) with a size of approximately 5 mm X 2.5 mm X 0.5 mm thick.
Technical Method Resorbable fixation devices are delivered via a pre-loaded manual surgical stapler delivery system.
Target Area Nasal septum.
Regulation Medical Specialty General & Plastic Surgery
Review Panel Ear Nose & Throat
Product CodeOLL
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Ear, Nose, and Throat Devices Branch (ENTB)
Submission Type 510(k)
Regulation Number 878.4750
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible