FDA 510(k) clearance · back to tracker

GENESIS INSUFFLATING CATHETER

General Medical Co. cleared K903669 on 1990-09-12, decision: substantially equivalent

K-number

K903669

Sponsor

General Medical Co.

Device

GENESIS INSUFFLATING CATHETER

Class

Class I

Decision

Substantially Equivalent

Decision date

1990-09-12

Product code

BSY

Advisory committee

Anesthesiology

Medical specialty

Anesthesiology

Regulation number

868.6810

Official FDA record

Open K903669on 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.