Clearance Summary
JTECH 50 SERIES CUTTING LOOP received FDA 510(k) clearance under submission number K913587, sponsored by J-Tech, 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 1991-10-23.
- Submission: K913587
- Applicant / Sponsor: J-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 1991-10-23
Classification & Regulation
This clearance is catalogued under FDA product code FJL and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.