FDA 510(k) clearance · back to tracker

URETERAL CATHETER AND ACCESSORIES

Urological Associates of Central Jersey P.A. cleared K934419 on 1994-05-25, decision: substantially equivalent

K-number

K934419

Sponsor

Urological Associates of Central Jersey P.A.

Device

URETERAL CATHETER AND ACCESSORIES

Class

Class I

Decision

Substantially Equivalent

Decision date

1994-05-25

Product code

EYK

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5130

Official FDA record

Open K934419on 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.

Use this as a predicate

Drop K934419 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.