Clearance Summary
GM501 Wash with Phenol Red and Gentamicin received FDA 510(k) clearance under submission number K192503, sponsored by Hamilton Thorne Incorporated. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2020-11-19.
- Submission: K192503
- Applicant / Sponsor: Hamilton Thorne Incorporated
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6180
- Decision date: 2020-11-19
Classification & Regulation
This clearance is catalogued under FDA product code MQL and 21 CFR 884.6180, within the Obstetrics/Gynecology review panel as a Class II device.