Clearance Summary
DIAMOND-TOUCH AND MICRO DIAMOND-TOUCH INSTRUMENTS/DIAMOND-LINE INSTRUMENTS/DIAMOND-PORT(ACCESS PARTS) received FDA 510(k) clearance under submission number K960400, sponsored by Snowden-Pencer. 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 1996-03-12.
- Submission: K960400
- Applicant / Sponsor: Snowden-Pencer
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5090
- Decision date: 1996-03-12
Classification & Regulation
This clearance is catalogued under FDA product code FBM and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class I device.