FDA 510(k) clearance · back to tracker

TROCAR CATHETER

Medovations, Inc. cleared K913678 on 1991-12-16, decision: substantially equivalent

K-number

K913678

Sponsor

Medovations, Inc.

Device

TROCAR CATHETER

Class

Class I

Decision

Substantially Equivalent

Decision date

1991-12-16

Product code

KGY

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4100

Official FDA record

Open K913678on 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.