Augustine Fiberoptic Laryngoscope

by Augustine Medical, Inc. 510(k)

Active United States

510(k) K915161

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK915161	Date29 May 1992Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K915161
FDA Product Code: CCW

Device Class: Class I
Regulation: 21 CFR Part 868.5540
Advisory Committee: Anesthesiology
FDA Decision: SESE Substantially Equivalent

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