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AbbVie PEG

by Abbvie Inc. 2 variants

510(k) K133087

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 NumberK133087 Date19 Jun 2014ClearedStatusActive

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  • Withdrawn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

Cited by

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

Overview

AI-generated summary, 1 Oct 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 PEG is a polyethylene glycol (PEG) electrolyte solution designed for bowel preparation prior to colonoscopy or other lower gastrointestinal procedures. It functions as an osmotic laxative to clear the colon by drawing water into the intestines, facilitating effective cleansing of the gastrointestinal tract.

This device is supplied as a powder for oral suspension and is intended for single-use. It is classified under product code KNT and has received FDA 510K clearance through a traditional review process. The solution must be reconstituted with water as directed and is intended for use in clinical settings such as hospitals, endoscopy centers, or outpatient care facilities.

Similar devices

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

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