510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K993385Substantially Equivalent

Autojet 2 (Non-Fixed Needle Type)

Owen Mumford USA, Inc., Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993385 is the FDA 510(k) clearance record for AUTOJET 2 (NON-FIXED NEEDLE TYPE), a class II device, cleared for Owen Mumford USA, Inc. on under FDA product code KZH (Introducer, Syringe Needle). FDA records list 10 510(k) clearances for Owen Mumford USA, Inc., from to . As of , FDA records show no recalls naming K993385.

Clearance record

Decision date
Received
(33 days to decision)
Product code
KZH Introducer, Syringe Needle
Regulation
21 CFR 880.6920
Device class
Class II
Review panel
General Hospital
Applicant
Owen Mumford USA, Inc. 849 Pickens Industrial Dr., Marietta GA
510(k) summary
Summary
Third party review
No

Clearances, product code KZH

Trailing 12 months

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

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