DeviceClearance

Product code NML— Gastroenterology, Urology

REPROCESSED GUIDEWIRES

Classification name
Catheter, Biliary, Reprocessed
Device class
Class 2
Regulation
21 CFR 876.5010
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

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).”

— U.S. Food and Drug Administration, device classification record for product code NML under 21 CFR 876.5010, via openFDA

Market context for product code NML

FDA has cleared 1 device under product code NML, all in 2002, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NML

Recent clearances under product code NML

Data sourced from openFDA. This site is unofficial and independent of the FDA.