Clearance Summary
MODIFIED SURGIQUEST AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM WITH INTEGRATED INSUFFLATOR DPIS 2000 received FDA 510(k) clearance under submission number K121336, sponsored by Surgiquest, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2012-07-03.
- Submission: K121336
- Applicant / Sponsor: Surgiquest, Inc.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 2012-07-03
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.