Olympus Angioscopy Sheath

by Olympus Corp. 510(k)

Active United States

510(k) K873100

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK873100	Date29 Feb 1988Cleared	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Withdrawn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: K873100
FDA Product Code: DYB

Device Class: Class II
Regulation: 21 CFR Part 870.1340
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

Other devices from Olympus Corp.

Olympus Direct Bilirubin Reagent

Class II
Olympus Chloride Reagent, Modification

Class II
Resectoscope Sheath

Class II
Olympus Measuring Devices

Class II
Sterile Disposable Cytology Brush

Not classified
Olympus Infant Resectoscope and Accessories

Class II

See all devices from Olympus Corp. →