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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, electrosurgical, active, urological, reprocessed
Definition The "electrode, electrosurgical, active, urological, reprocessed" is intended to be used endoscopically to contact urologic tissue so as to allow cutting, coagulation, electrodesiccation, or cautery dessication by means of electric current. 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) 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 CodeNLW
Regulation Number 876.4300
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1

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