510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K834164Substantially Equivalent

Spinal Needles & Accessory

Elfa Trading Co., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834164 is the FDA 510(k) clearance record for SPINAL NEEDLES & ACCESSORY, a class II device, cleared for Elfa Trading Co. on under FDA product code FPK (Tubing, Fluid Delivery). FDA records list 2 510(k) clearances for Elfa Trading Co. As of , FDA records show no recalls naming K834164.

Clearance record

Decision date
Received
(12 days to decision)
Product code
FPK Tubing, Fluid Delivery
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Elfa Trading Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FPK

Trailing 12 months

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

FDA records show no clearances under product code FPK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPK, 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