Clearance Summary
Insufflator (OPTO-IFL1000) received FDA 510(k) clearance under submission number K252318, sponsored by Guangdong Optomedic Technologies, 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 2026-04-16.
- Submission: K252318
- Applicant / Sponsor: Guangdong Optomedic Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1730
- Decision date: 2026-04-16
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.