FDA 510(k) clearance · back to tracker

VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)

Advanced Care Medical Products cleared K972100 on 1997-07-31, decision: substantially equivalent

K-number

K972100

Sponsor

Advanced Care Medical Products

Device

VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)

Class

Class I

Decision

Substantially Equivalent

Decision date

1997-07-31

Product code

EXJ

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5250

Official FDA record

Open K972100on accessdata.fda.gov →

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

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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.