Clearance Summary
INSTRUMED FORCEPS OBSTETRICAL/GYNAECOLOGICAL received FDA 510(k) clearance under submission number K092840, sponsored by Instrumed International, Inc.. 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 2009-12-03.
- Submission: K092840
- Applicant / Sponsor: Instrumed International, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2009-12-03
Classification & Regulation
This clearance is catalogued under FDA product code HCZ and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.