NML

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Catheter, Biliary, Reprocessed

Device class

Class II (moderate risk)

Regulation

21 CFR 876.5010

Medical specialty

Gastroenterology, Urology

Flags

Third-party review eligible

FDA definition

same as "FGE" except being reprocessed. 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).

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