Avanos 98492

by Avanos Medical, Inc.

Avanos 98492 (2120-16-2.0) is a Class II device made by Avanos Medical, Inc., cleared under FDA 510(k) K043114 on 10 Dec 2004 and listed in FDA GUDID since 20 Feb 2019 (UDI-DI 00350770984926), active as of 23 Oct 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 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00350770984926 UDI-DI	Date20 Feb 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK043114	Date10 Dec 2004Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00350770984926
FDA 510(k) database 510(k) number K043114

Across registries

2 registries list this device

FDA 510(k) K043114 decided 10 Dec 2004 Active
FDA GUDID UDI-DI 00350770984926 listed 20 Feb 2019 Listed

Timeline

2 dated events

10 Dec 2004 Cleared FDA 510(k) K043114
20 Feb 2019 Listed FDA GUDID 00350770984926

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Avanos
Generic name: Gastrostomy button
Model / Ref / Catalog: 98492, 2120-16-2.0

Primary DI / UDI-DI: 00350770984926
510(k) Number: K043114
FDA product code: KNT
GMDN term: Gastrostomy button

Device class: Class II
Regulation number: 876.5980
GUDID distribution status: In Commercial Distribution

MRI safety: MR Conditional

Size: Catheter Gauge — 16 French

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Properties

Supplied sterile
Single use
Implantable
Lot / batch number
Expiration date
Manufacturing date

Other properties (9, all answered No)