FDA 510(k) clearance · back to tracker

COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER

Sierra Laboratories, Inc. cleared K962384 on 1996-07-15, decision: substantially equivalent

K-number

K962384

Sponsor

Sierra Laboratories, Inc.

Device

COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER

Class

Class I

Decision

Substantially Equivalent

Decision date

1996-07-15

Product code

EXJ

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5250

Official FDA record

Open K962384on 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 K962384 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.