AUTOJECT 2— 510(k) K013362

Name: FDA 510(k) clearance K013362
Creator: U.S. Food and Drug Administration
Published: 2001-11-13

Substantially Equivalent

Owen Mumford USA, Inc.

FDA 510(k) clearance K013362 for AUTOJECT 2, Substantially Equivalent on 2001-11-13. Applicant: Owen Mumford USA, Inc.. Device class: 2.

Clearance details

Applicant: Owen Mumford USA, Inc.
Product code: Code KZH
Device class: Class 2
Regulation: 21 CFR 880.6920
Advisory panel: General Hospital
Date received: 2001-10-10
Decision date: 2001-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KZH

view all

K243232 — GripMate2024-12-02
K213429 — AccuSert Needle Inserter2022-10-20
K163400 — Orbit Inserter2017-07-26
K160860 — MiniMed Quick-serter2016-09-22
K141384 — WHISPERJECT AUTOINJECTOR2014-09-12

More clearances from Owen Mumford USA, Inc.

view all

K993385 — AUTOJET 2 (NON-FIXED NEEDLE TYPE)1999-11-10
K983994 — UNIFINE1999-01-08
K983974 — OWEN MUMFORD 3ML AUTOPEN1998-12-21
K982275 — RAPPORT V.T.D.1998-12-04
K983045 — AMIELLE1998-11-25

Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.