Clearance Summary
NASOGASTRIC PH SUCTION CATHETER, ST-5001 received FDA 510(k) clearance under submission number K891410, sponsored by Sensatronix Medical Systems, 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 1989-06-23.
- Submission: K891410
- Applicant / Sponsor: Sensatronix Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1400
- Decision date: 1989-06-23
Classification & Regulation
This clearance is catalogued under FDA product code FFT and 21 CFR 876.1400, within the Gastroenterology, Urology review panel as a Class I device.