Clearance Summary
FEMASSIST FLEXIBLE received FDA 510(k) clearance under submission number K974645, sponsored by Insight Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1998-02-12.
- Submission: K974645
- Applicant / Sponsor: Insight Medical Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5160
- Decision date: 1998-02-12
Classification & Regulation
This clearance is catalogued under FDA product code MNG and 21 CFR 876.5160, within the Gastroenterology, Urology review panel as a Class I device.