Clearance Summary
HIGH TEMPERATURE CAUTERY ELONGATED FINE TIP received FDA 510(k) clearance under submission number K945764, sponsored by Aaron Medical Industries. 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 1995-01-30.
- Submission: K945764
- Applicant / Sponsor: Aaron Medical Industries
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 1995-01-30
Classification & Regulation
This clearance is catalogued under FDA product code KNS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.