FDA 510(k) clearance · back to tracker

NASOGASTRIC PH SUCTION CATHETER, ST-5001

Sensatronix Medical Systems, Inc. cleared K891410 on 1989-06-23, decision: substantially equivalent

K-number

K891410

Sponsor

Sensatronix Medical Systems, Inc.

Device

NASOGASTRIC PH SUCTION CATHETER, ST-5001

Class

Class I

Decision

Substantially Equivalent

Decision date

1989-06-23

Product code

FFT

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1400

Official FDA record

Open K891410on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.