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Septal Stapler/Absorbable Staples

Page Type
Product Code
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 and Plastic Surgery
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4750
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4750 Implantable staple

§ 878.4750 Implantable staple.

(a) Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

(b) Classification. Class II.

Septal Stapler/Absorbable Staples

Page Type
Product Code
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 and Plastic Surgery
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4750
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4750 Implantable staple

§ 878.4750 Implantable staple.

(a) Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

(b) Classification. Class II.