Last synced on 25 November 2022 at 11:04 pm

Temporary Tissue Marker

Page Type
Product Code
Definition
To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.
Physical State
May include: implantable marker, delivery device
Technical Method
Marks a tissue location by being visible using imaging techniques.
Target Area
Tissue intended to be removed surgically
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4300 Implantable clip

§ 878.4300 Implantable clip.

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

(b) Classification. Class II.

Temporary Tissue Marker

Page Type
Product Code
Definition
To temporarily (< 30 days) mark a tissue site intended for surgical removal. The tissue marker is surgically removed with the target tissue.
Physical State
May include: implantable marker, delivery device
Technical Method
Marks a tissue location by being visible using imaging techniques.
Target Area
Tissue intended to be removed surgically
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 878.4300 Implantable clip

§ 878.4300 Implantable clip.

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

(b) Classification. Class II.