DeviceClearance

Product code KOH— Obstetrics/Gynecology

C-SECTION PACK

Classification name
Instrument, Manual, General Obstetric-Gynecologic
Device class
Class 1
Regulation
21 CFR 884.4520
Advisory panel
Obstetrics/Gynecology
Total cleared
15
First cleared
Most recent

Market context for product code KOH

FDA has cleared 15 devices under product code KOH between 1978 and 2000, filed by 12 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 KOH

Recent clearances under product code KOH

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