510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K024120Substantially Equivalent

Modification to Temno Biopsy Needles

Medtronic, Inc., Mcgaw Park IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K024120 is the FDA 510(k) clearance record for MODIFICATION TO TEMNO BIOPSY NEEDLES, a class II device, cleared for Allegiance Healthcare Corp. on under FDA product code FCG (Biopsy Needle). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K024120.

Clearance record

Decision date
Received
(30 days to decision)
Product code
FCG Biopsy Needle
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Allegiance Healthcare Corp. 1500 Waukegan Rd. Mpwm-1e, Mcgaw Park IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FCG

Trailing 12 months

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

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