Clearance Summary
FORCEPS, SURGICAL, GYNECOLOGICAL received FDA 510(k) clearance under submission number K892820, sponsored by The South India Surgical Co. Pvt. , 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 1989-06-22.
- Submission: K892820
- Applicant / Sponsor: The South India Surgical Co. Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1989-06-22
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.