Product code HGD— Obstetrics/Gynecology
THE KLINE APPLICATOR
- Classification name
- Applicator, Vaginal
- Device class
- Class 1
- Regulation
- 21 CFR 884.4520
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code HGD
FDA has cleared device under product code HGD, all in 1983, filed by 1 applicant company. 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.
Top applicants under product code HGD
Recent clearances under product code HGD
Data sourced from openFDA. This site is unofficial and independent of the FDA.