NUBClass III

Colonic Irrigation System, General Well Being

21 CFR 876.5220 / Gastroenterology, Urology

NUB is the FDA product code for Colonic Irrigation System, General Well Being, a class III device type, regulated under 21 CFR 876.5220. FDA's definition for this code reads: "Call for PMAs on 12/26/96 per 61 FR 50707 on 9/27/96 - Colon cleansing for routine general well being". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: NUB
Device name: Colonic Irrigation System, General Well Being
FDA definition: Call for PMAs on 12/26/96 per 61 FR 50707 on 9/27/96 - Colon cleansing for routine general well being
Regulation: 21 CFR 876.5220
Device class: Class III
Review panel: Gastroenterology, Urology
Submission type: PMA
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code NUB.

Recent clearances

Product code NUB

FDA records hold no clearances under product code NUB.

Recent recalls

Product code NUB

FDA records show no recalls under product code NUB.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)