Clearance Summary
IM-11 PNEUMATIC MICROINJECTOR received FDA 510(k) clearance under submission number K113712, sponsored by Narishige 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 2012-03-15.
- Submission: K113712
- Applicant / Sponsor: Narishige Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6150
- Decision date: 2012-03-15
Classification & Regulation
This clearance is catalogued under FDA product code MQJ and 21 CFR 884.6150, within the Obstetrics/Gynecology review panel as a Class II device.