Clearance Summary
INSITE MODEL 20 & MODEL 15 INSUFFLATORS received FDA 510(k) clearance under submission number K934926, sponsored by Andronic Devices, 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 1994-05-26.
- Submission: K934926
- Applicant / Sponsor: Andronic Devices, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1994-05-26
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.