Clearance Summary
INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX received FDA 510(k) clearance under submission number K100517, 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 2010-04-29.
- Submission: K100517
- Applicant / Sponsor: Instrumed International, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4400
- Decision date: 2010-04-29
Classification & Regulation
This clearance is catalogued under FDA product code HDA and 21 CFR 884.4400, within the Obstetrics/Gynecology review panel as a Class II device.