FDA 510(k) clearance · back to tracker

SILICONE MALE EXTERNAL CATHETER

Mentor Corp. cleared K913524 on 1991-10-04, decision: substantially equivalent

K-number

K913524

Sponsor

Mentor Corp.

Device

SILICONE MALE EXTERNAL CATHETER

Class

Class I

Decision

Substantially Equivalent

Decision date

1991-10-04

Product code

EXJ

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5250

Official FDA record

Open K913524on 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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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.