510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962017Substantially Equivalent

Hypodermic Jet Injection Apparatus

American Jet Injector Corp., Lansdale PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962017 is the FDA 510(k) clearance record for HYPODERMIC JET INJECTION APPARATUS, a class II device, cleared for American Jet Injector Corp. on under FDA product code EGM (Injector, Jet, Mechanical-Powered). FDA records list one 510(k) clearance for American Jet Injector Corp. As of , FDA records show no recalls naming K962017.

Clearance record

Decision date
Received
(64 days to decision)
Product code
EGM Injector, Jet, Mechanical-Powered
Regulation
21 CFR 872.4475
Device class
Class II
Review panel
Dental
Applicant
American Jet Injector Corp. 880 Orchard Ln., Lansdale PA
510(k) summary
Statement
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