Flexible Fiberscopes and Accessories

by Richard Wolf Medical Instruments Corp. 510(k)

Active United States

510(k) K980401

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK980401	Date21 May 1998Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
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: K980401
FDA Product Code: FAJ

Device Class: Class II
Regulation: 21 CFR Part 876.1500
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

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