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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device forceps, biopsy, electric, reprocessed
Regulation Description Endoscopic electrosurgical unit and accessories.
Definition The "forceps, biopsy, electric, reprocessed" are intended to be used endoscopically and use electric current to (1) obtain tissue samples for histopathological examination, (2) allow for coagulation so as to prevent bleeding, and (3) destroy the residuum of the lesion being biopsied. This device is indicated for reuse/reprocessing. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNLU
Regulation Number 876.4300
Device Class 2

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