Product code HGZ— Obstetrics/Gynecology
E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES
- Classification name
- Heater, Perineal, Direct Contact
- Device class
- Class 2
- Regulation
- 21 CFR 884.5390
- Advisory panel
- Obstetrics/Gynecology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code HGZ
FDA has cleared device under product code HGZ, all in 1994, filed by 1 applicant company. 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.
Top applicants under product code HGZ
Recent clearances under product code HGZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.