Causse / Flex H/A® 0529

by Medtronic Xomed Inc

Causse / Flex H/A® 0529 is a Class II device made by Medtronic Xomed Inc, cleared under FDA 510(k) K904239 on 21 Jun 1991 and listed in FDA GUDID since 7 Nov 2021 (UDI-DI 00763000034474), active as of 8 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00763000034474 UDI-DI	Date7 Nov 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK904239	Date21 Jun 1991Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00763000034474
FDA 510(k) database 510(k) number K904239

Across registries

2 registries list this device

FDA 510(k) K904239 decided 21 Jun 1991 Active
FDA GUDID UDI-DI 00763000034474 listed 7 Nov 2021 Listed

Timeline

2 dated events

21 Jun 1991 Cleared FDA 510(k) K904239
7 Nov 2021 Listed FDA GUDID 00763000034474

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Causse / Flex H/A®
Generic name: Ossicular prosthesis, total
Model / reference: 0529

Primary DI / UDI-DI: 00763000034474
510(k) Number: K904239
FDA product code: ETA
GMDN term: Ossicular prosthesis, total

Device class: Class II
Regulation number: 874.3495
GUDID distribution status: In Commercial Distribution

MRI safety: MR Conditional

Size: Length — 9.0 Millimeter

Other devices from Medtronic Xomed Inc

See all devices from Medtronic Xomed Inc →

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number

Other properties (10, all answered No)