FDA 510(k) clearance · back to tracker

ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER

Rochester Medical Corp. cleared K952082 on 1995-07-18, decision: substantially equivalent

K-number

K952082

Sponsor

Rochester Medical Corp.

Device

ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER

Class

Class I

Decision

Substantially Equivalent

Decision date

1995-07-18

Product code

EXJ

Advisory committee

Gastroenterology, Urology

Medical specialty

Gastroenterology, Urology

Regulation number

876.5250

Official FDA record

Open K952082on 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 K952082 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.