510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864294Substantially Equivalent

Henke-Ject Pressure Syringe (Modification)

Smith & Nephew, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864294 is the FDA 510(k) clearance record for HENKE-JECT PRESSURE SYRINGE (MODIFICATION), a class II device, cleared for Smith & Nephew, Inc. on under FDA product code EGM (Injector, Jet, Mechanical-Powered). FDA records list 572 510(k) clearances for Smith & Nephew, Inc., from to . As of , FDA records show no recalls naming K864294.

Clearance record

Decision date
Received
(369 days to decision)
Product code
EGM Injector, Jet, Mechanical-Powered
Regulation
21 CFR 872.4475
Device class
Class II
Review panel
Dental
Applicant
Smith & Nephew, Inc. 1820 W. Roscoe St., Chicago IL
Third party review
No

Clearances, product code EGM

Trailing 12 months

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

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