NML

Catheter, Biliary, Reprocessed

Product code

NML

Device name

Catheter, Biliary, Reprocessed

Device class

Class 2

21 CFR

21 CFR 876.5010

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).