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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device unit, electrosurgical, endoscopic (with or without accessories), reprocessed
Regulation Description Endoscopic electrosurgical unit and accessories.
Definition This device is intended to be used endoscopically to remove tissue and control bleeding by use of high frequency electrical 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).
Product CodeNLR
Regulation Number 876.4300
Device Class 2

MDR Year MDR Reports MDR Events
2023 1 1
2025 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1
Insufficient Information 1 1

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