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U.S. Department of Health and Human Services

Product Classification
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Device temporary tissue marker
Regulation Description Implantable clip.
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 & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePBY
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 878.4300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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