Clearance Summary
INSUFFALATOR LAPARAOSCOPIC received FDA 510(k) clearance under submission number K781913, 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 1978-12-04.
- Submission: K781913
- Applicant / Sponsor: Kli
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1978-12-04
Classification & Regulation
This clearance is catalogued under FDA product code HIF and 21 CFR 884.1730, within the Obstetrics/Gynecology review panel as a Class II device.