DeviceClearance

Product code KZH— General Hospital

AUTOJECT 2

Classification name
Introducer, Syringe Needle
Device class
Class 2
Regulation
21 CFR 880.6920
Advisory panel
General Hospital
Total cleared
47
First cleared
Most recent

Market context for product code KZH

FDA has cleared 47 devices under product code KZH between 1979 and 2024, filed by 37 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code KZH

Adverse events under product code KZH

product code KZH
Other
1
Total
1

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

Recent clearances under product code KZH

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