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AbbVie PEG 62912

by Abbvie Inc.

AbbVie PEG 62912 is a Class II device made by Abbvie Inc., cleared under FDA 510(k) K142793 on 14 Jan 2015 and listed in FDA GUDID since 15 Apr 2019 (UDI-DI 08054083004976), active as of 23 Oct 2026. 4 FDA recalls are linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

510(k) K142793

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08054083004976 UDI-DI Date15 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESK from GUDID Substantially Equivalent — Kit · Traditional NumberK142793 Date14 Jan 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142793 decided 14 Jan 2015 Active
  • FDA GUDID UDI-DI 08054083004976 listed 15 Apr 2019 Listed

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2177-2017 FDA Class II initiated 27 Apr 2017
    • Terminated Z-2178-2017 FDA Class II initiated 27 Apr 2017

    PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.

    • Terminated Z-2176-2017 FDA Class II initiated 27 Apr 2017
    • Terminated Z-0786-2017 FDA Class II initiated 22 Nov 2016

    AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.

Timeline

6 dated events

  1. Cleared FDA 510(k) K142793
  2. Recall initiated FDA recalls Z-0786-2017
  3. Recall initiated FDA recalls Z-2177-2017
  4. Recall initiated FDA recalls Z-2178-2017
  5. Recall initiated FDA recalls Z-2176-2017
  6. Listed FDA GUDID 08054083004976

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AbbVie PEG
Generic name
Gastrostomy tube
Model / reference
62912
Primary DI / UDI-DI
08054083004976
510(k) Number
FDA product code
KNT
GMDN term
Gastrostomy tube
Device class
Class II
Regulation number
876.5980
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gastrostomy tube

Cleared under the same submission (K142793)

Similar devices in this category

Other devices filed under Gastrostomy tube.

Other devices from Abbvie Inc.

See all devices from Abbvie Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)