Clearance Summary
DISPOSABLE, FILTERED INSUFFLATION TUBING, 92-900 received FDA 510(k) clearance under submission number K921963, sponsored by Sun Medical, 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 1992-09-11.
- Submission: K921963
- Applicant / Sponsor: Sun Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 1992-09-11
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.