Afx Introducer System

by Endologix LLC 2 variants

510(k) K110090

Afx Introducer System is a Class II device made by Endologix LLC, cleared under FDA 510(k) K110090 on 26 May 2011, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K110090↗

FDA record

Trust

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK110090	Date26 May 2011Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K110090

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K110090
FDA product code: DYB
FDA applicant: Endologix, Inc.

Device class: Class II
Regulation: 21 CFR Part 870.1340
Advisory committee: Cardiovascular
FDA decision: SESE Substantially Equivalent

Other devices from Endologix LLC

ENDOCROSS Device

Class III
TORUS Stent Graft System TSG-5.5X200

Class III
TORUS Stent Graft System TSG-6.0X100

Class III
TORUS Stent Graft System TSG-6.0X150

Class III

See all devices from Endologix LLC →