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AbbVie J

by Abbvie Inc.

510(k) K142816

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK142816 Date14 Jan 2015ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KNT
FDA applicant
AbbVie , Inc.
Device class
Class II
Regulation
21 CFR Part 876.5980
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The AbbVie J is a ureteral access sheath (product code KNT), a tubular device designed to facilitate the insertion and manipulation of ureteroscopes within the ureter for diagnostic and therapeutic procedures. It provides a protected pathway for instruments, reducing trauma to the ureteral walls while enabling clearer visualization and improved access during interventions such as stone removal or biopsy.

Supplied as a single-use device, the AbbVie J is intended for use in urological settings, including operating rooms and endoscopy suites. It is cleared by the FDA under 510K (K142816) as substantially equivalent to a predicate device, with no third-party involvement. Sterility and sizing details are not specified in the submission data, but compliance with 510K clearance ensures adherence to regulatory standards for ureteral sheaths in urological procedures.

Devices cleared under K142816

7 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K142816
UDI-DISize and differences
AbbVie Click Adaptor 62922
ABBVIE INC.
6292208054083004884 —On the market
AbbVie J 62918
ABBVIE INC.
6291808054083004860 —On the market
AbbVie J AV062
ABBVIE INC.
AV06208054083014432 —On the market
Medline Industries, Inc. ABBVIE15FR
MEDLINE INDUSTRIES, INC.
ABBVIE15FR / ABBVIE15FR10889942149162 —On the market
Medline Industries, Inc. ABBVIE20FR
MEDLINE INDUSTRIES, INC.
ABBVIE20FR / ABBVIE20FR10889942149155 —On the market
Y-Connector for AbbVie PEG 15 FR 62924
ABBVIE INC.
6292408054083004907 —On the market
Y-Connector for AbbVie PEG 20 FR 62926
ABBVIE INC.
6292628054083004918 —On the market

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. →