Clearance Summary
HIFLO FILTERED INSUFFLATION TUBING received FDA 510(k) clearance under submission number K930508, sponsored by W. J. Medical Instruments, Inc.. 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 1993-06-25.
- Submission: K930508
- Applicant / Sponsor: W. J. Medical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1993-06-25
Classification & Regulation
This clearance is catalogued under FDA product code FCX and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.