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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dislodger, stone, flexible, ureteral, reprocessed
Definition A ureteral stone dislodger is a device that consists of a bougie or a catheter with a special flexible tip. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. 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 CodeNQT
Regulation Number 876.4680
Device Class 2

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