NLNClass II

Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed

21 CFR 882.4310 / Neurology

NLN is the FDA product code for Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed, a class II device type, regulated under 21 CFR 882.4310. FDA's definition for this code reads: "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)". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2004-11-23, and no recalls.

Classification record

Product code: NLN
Device name: Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
FDA 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).
Regulation: 21 CFR 882.4310
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code NLN

By decision year

1 clearance under product code NLN with a decision year between 2004 and 2004, 2004 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code NLN by decision year
Year	Clearances
2004	1

Applicants with the most clearances

Product code NLN

Applicants holding the most 510(k) clearances under product code NLN
Applicant	Clearances
Alliance Medical Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NLN.

Recent clearances

Product code NLN

K041978Class IIReprocessed Diamond BursAlliance Medical Corp. / cleared 2004-11-23

Recent recalls

Product code NLN

FDA records show no recalls under product code NLN.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)