FCBClass II

Bag, Hemostatic

21 CFR 876.5980 / Gastroenterology, Urology

FCB is the FDA product code for Bag, Hemostatic, a class II device type, regulated under 21 CFR 876.5980. As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: FCB
Device name: Bag, Hemostatic
Regulation: 21 CFR 876.5980
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

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

Recent clearances

Product code FCB

FDA records hold no clearances under product code FCB.

Recent recalls

Product code FCB

Z-0347-2024Class IIChannel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet...Aizu Olympus Co., Ltd. / initiated 2023-09-25 / 1577 units

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)