HGZ — Heater, Perineal, Direct Contact Class II
FDA product code HGZ covers "Heater, Perineal, Direct Contact", a Class II medical device regulated under 21 CFR 884.5390. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- HGZ
- Device Class
- Class II
- Regulation Number
- 884.5390
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K921885 | valleylab | E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES | March 25, 1994 |