FDA 510(k) clearance · back to tracker

DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K

Bentec Medical, Inc. cleared K971411 on 1997-06-03, decision: substantially equivalent

K-number

K971411

Sponsor

Bentec Medical, Inc.

Device

DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K

Class

Class I

Decision

Substantially Equivalent

Decision date

1997-06-03

Product code

EMX

Advisory committee

Ear, Nose, Throat

Medical specialty

Ear, Nose, Throat

Regulation number

874.4100

Official FDA record

Open K971411on 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.

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Drop K971411 into Compass and start a substantial-equivalence draft.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.