FDA 510(k) clearance · back to tracker

SUCTION CATHETER STRAIGHT/COUDE

Unoplast A/S cleared K896730 on 1990-03-30, decision: substantially equivalent

K-number

K896730

Sponsor

Unoplast A/S

Device

SUCTION CATHETER STRAIGHT/COUDE

Class

Class I

Decision

Substantially Equivalent

Decision date

1990-03-30

Product code

BSY

Advisory committee

Anesthesiology

Medical specialty

Anesthesiology

Regulation number

868.6810

Official FDA record

Open K896730on 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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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.