EXB

Collector, Ostomy

Product code
EXB
Device name
Collector, Ostomy
Device class
Class 1
21 CFR
21 CFR 876.5900
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K) Exempt
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
102 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-10-06.

NumberDecision dateApplicantDevice nameSummary
K2521402025-10-06Coloplast Corp.Heylo™ SystemPDF

1 summaries are archived here for direct download.

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