PENTAX Medical Video Bronchoscope EB11-J10

by PENTAX of America, Inc. United States 510(k)

510(k) K210928 Product code EOQ

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK210928	Date21 Oct 2021Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K210928
FDA Product Code: EOQ

Device Class: Class II
Regulation: 21 CFR Part 874.4680
Advisory Committee: Ear, Nose, Throat
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K210928 24 fields · synced 22 Oct 2026