510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830524Substantially Equivalent

Henke Ject Pressure Syringe

Smith & Nephew, Mpl Division, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830524 is the FDA 510(k) clearance record for HENKE JECT PRESSURE SYRINGE, a class II device, cleared for Smith & Nephew, Mpl Division on under FDA product code EJI (Syringe, Cartridge). FDA records list 9 510(k) clearances for Smith & Nephew, Mpl Division, from to . As of , FDA records show no recalls naming K830524.

Clearance record

Decision date
Received
(35 days to decision)
Product code
EJI Syringe, Cartridge
Regulation
21 CFR 872.6770
Device class
Class II
Review panel
Dental
Applicant
Smith & Nephew, Mpl Division 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EJI

Trailing 12 months

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

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