Clearance Summary
ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE received FDA 510(k) clearance under submission number K981256, sponsored by Ximed/Prosure/Injectx. 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 1998-05-12.
- Submission: K981256
- Applicant / Sponsor: Ximed/Prosure/Injectx
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.4300
- Decision date: 1998-05-12
Classification & Regulation
This clearance is catalogued under FDA product code FAS and 21 CFR 876.4300, within the Gastroenterology, Urology review panel as a Class II device.