Clearance Summary
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes received FDA 510(k) clearance under submission number K202176, sponsored by Medical Components, Inc. (dba MedComp). The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2020-09-03.
- Submission: K202176
- Applicant / Sponsor: Medical Components, Inc. (dba MedComp)
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5540
- Decision date: 2020-09-03
Classification & Regulation
This clearance is catalogued under FDA product code MSD and 21 CFR 876.5540, within the Gastroenterology, Urology review panel as a Class II device.