DeviceClearance

Product code KOZ— General, Plastic Surgery

ALLEVYN DRESSING CLAIMS CHANGE

Classification name
Beads, Hydrophilic, For Wound Exudate Absorption
Device class
Class 1
Regulation
21 CFR 878.4018
Advisory panel
General, Plastic Surgery
Total cleared
22
First cleared
Most recent

Market context for product code KOZ

FDA has cleared 22 devices under product code KOZ between 1976 and 1991, filed by 16 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code KOZ

Adverse events under product code KOZ

product code KOZ
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 KOZ

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