Clearance Summary
JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER received FDA 510(k) clearance under submission number K935247, sponsored by Jedmed Instrument Co.. 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 1994-02-18.
- Submission: K935247
- Applicant / Sponsor: Jedmed Instrument Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1500
- Decision date: 1994-02-18
Classification & Regulation
This clearance is catalogued under FDA product code FEA and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class I device.