Clearance Summary
OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH received FDA 510(k) clearance under submission number K051742, sponsored by Inntec, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2005-10-07.
- Submission: K051742
- Applicant / Sponsor: Inntec, Inc.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6100
- Decision date: 2005-10-07
Classification & Regulation
This clearance is catalogued under FDA product code MQE and 21 CFR 884.6100, within the Obstetrics/Gynecology review panel as a Class II device.