Clearance Summary
ONE INCISION BI-POLAR ELECTRO. FORCEPS received FDA 510(k) clearance under submission number K781089, sponsored by Kli. 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 1978-07-17.
- Submission: K781089
- Applicant / Sponsor: Kli
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4150
- Decision date: 1978-07-17
Classification & Regulation
This clearance is catalogued under FDA product code HIN and 21 CFR 884.4150, within the Obstetrics/Gynecology review panel as a Class II device.