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Avanos 7120-14-1.2

by Avanos Medical, Inc.

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

510(k) K043114

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00350770287249 UDI-DI Date11 Jul 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK043114 Date10 Dec 2004DecidedStatusActive

Official records

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Avanos
Generic name
Gastrostomy button
Model / Ref / Catalog
7120-14-1.2
Primary DI / UDI-DI
00350770287249
510(k) Number
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 — 14 French

Related devices

Category: Gastrostomy button

Cleared under the same submission (K043114)

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Other devices from Avanos Medical, Inc.

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Properties

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

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No