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AbbVie J 62918

by Abbvie Inc.

AbbVie J 62918 is a Class II device made by Abbvie Inc., cleared under FDA 510(k) K142816 on 14 Jan 2015 and listed in FDA GUDID since 15 Apr 2019 (UDI-DI 08054083004860), 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

510(k) K142816

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 Number08054083004860 UDI-DI Date15 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK142816 Date14 Jan 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K142816 decided 14 Jan 2015 Active
  • FDA GUDID UDI-DI 08054083004860 listed 15 Apr 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K142816
  2. Listed FDA GUDID 08054083004860

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AbbVie J
Generic name
Jejunostomy tube
Model / reference
62918
Primary DI / UDI-DI
08054083004860
510(k) Number
FDA product code
KNT
GMDN term
Jejunostomy tube
Device class
Class II
Regulation number
876.5980
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Jejunostomy tube

Cleared under the same submission (K142816)

and 2 more cleared under K142816

Similar devices

Also classified as Jejunostomy tube.

Similar devices

Other devices filed under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)).

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)