Clearance Summary
INSUFFLATION NEEDLE- 120MM, MODEL 900-200 received FDA 510(k) clearance under submission number K993625, sponsored by Genicon, LC. 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 2000-06-20.
- Submission: K993625
- Applicant / Sponsor: Genicon, LC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 2000-06-20
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.