Clearance Summary
RUMBLE TUFF received FDA 510(k) clearance under submission number K113315, sponsored by Acute Ideas Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2012-11-20.
- Submission: K113315
- Applicant / Sponsor: Acute Ideas Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2012-11-20
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.