FDA 510(k) clearance · back to tracker

MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION

Synectics-Dantec cleared K913817 on 1992-06-11, decision: substantially equivalent

K-number

K913817

Sponsor

Synectics-Dantec

Device

MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION

Class

Class I

Decision

Substantially Equivalent

Decision date

1992-06-11

Product code

FFT

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.1400

Official FDA record

Open K913817on 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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Drop K913817 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

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Source

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