510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041978Substantially Equivalent

Reprocessed Diamond Burs

Alliance Medical Corp., Phoenix AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041978 is the FDA 510(k) clearance record for REPROCESSED DIAMOND BURS, a class II device, cleared for Alliance Medical Corp. on under FDA product code NLN (Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed). FDA's definition for product code NLN 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)". FDA records list 47 510(k) clearances for Alliance Medical Corp., from to . As of , FDA records show no recalls naming K041978.

Clearance record

Decision date
Received
(123 days to decision)
Product code
NLN Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
Regulation
21 CFR 882.4310
Device class
Class II
Review panel
Neurology
Applicant
Alliance Medical Corp. 10232 S. 51st St., Phoenix AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NLN

Trailing 12 months

FDA records hold no clearances under product code NLN in the trailing twelve months.

FDA records show no clearances under product code NLN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NLN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260