FDA 510(k) clearance · back to tracker

FOLEY CATHETER TUBE HOLDER NO. 101

Ansley Medical Products, Inc. cleared K924567 on 1992-11-23, decision: substantially equivalent

K-number

K924567

Sponsor

Ansley Medical Products, Inc.

Device

FOLEY CATHETER TUBE HOLDER NO. 101

Class

Class I

Decision

Substantially Equivalent

Decision date

1992-11-23

Product code

KMK

Advisory committee

General Hospital

Medical specialty

General Hospital

Regulation number

880.5210

Official FDA record

Open K924567on 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.