EXQ

Cystometer, Electrical Recording

Product code
EXQ
Device name
Cystometer, Electrical Recording
Device class
Class 2
21 CFR
21 CFR 876.1620
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K) Exempt
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
8 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-04-16.

NumberDecision dateApplicantDevice nameSummary
K2535372026-04-16Bright Uro, Inc.Glean Urodynamics System Male Delivery System (GUS-1PDF
K2430522025-03-24Bright Uro, Inc.Glean Urodynamics System Male Delivery System (GUS-1PDF

2 summaries are archived here for direct download.

Official FDA classification page: EXQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).