Clearance Summary
ENDOSCOPIC ANTI-FOG KIT, 100-302-00 received FDA 510(k) clearance under submission number K933520, sponsored by Avail-Southwest Division. 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 1993-08-24.
- Submission: K933520
- Applicant / Sponsor: Avail-Southwest Division
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1993-08-24
Classification & Regulation
This clearance is catalogued under FDA product code GCJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.