NASOGASTRIC PH SUCTION CATHETER, ST-5001— 510(k) K891410

Name: FDA 510(k) clearance K891410
Creator: U.S. Food and Drug Administration
Published: 1989-06-23

Substantially Equivalent

Sensatronix Medical Systems, Inc.

FDA 510(k) clearance K891410 for NASOGASTRIC PH SUCTION CATHETER, ST-5001, Substantially Equivalent on 1989-06-23. Applicant: Sensatronix Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Sensatronix Medical Systems, Inc.
Product code: Code FFT
Device class: Class 1
Regulation: 21 CFR 876.1400
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-14
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: So. Plainfield, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FFT

product code FFT

Injury: 595
Malfunction: 2,175
Other: 1
Total: 2,771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.