Clearance Summary
MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND P50 received FDA 510(k) clearance under submission number K980980, sponsored by Konigsberg Instruments, 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 1998-06-15.
- Submission: K980980
- Applicant / Sponsor: Konigsberg Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 1998-06-15
Classification & Regulation
This clearance is catalogued under FDA product code FFX and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.