DeviceClearance

Product code NLN— Neurology

REPROCESSED DIAMOND BURS

Classification name
Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
Device class
Class 2
Regulation
21 CFR 882.4310
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“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 NLN under 21 CFR 882.4310, via openFDA

Market context for product code NLN

FDA has cleared 1 device under product code NLN, all in 2004, 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 NLN

Recent clearances under product code NLN

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