FDA 510(k) clearance · back to tracker

PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10

Pentax of America, Inc. cleared K220465 on 2022-11-16, decision: substantially equivalent

K-number

K220465

Sponsor

Pentax of America, Inc.

Device

PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10

Class

Class II

Decision

Substantially Equivalent

Decision date

2022-11-16

Product code

EOB

Advisory committee

Ear, Nose, Throat

Medical specialty

Ear, Nose, Throat

Regulation number

874.4760

Official FDA record

Open K220465on 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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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.