FCBClass II

Bag, Hemostatic

Gastroenterology, Urology · 21 CFR 876.5980

MDR events2All time

Recalls1All time

Registered firms0Currently listed

510(k) clearances0All time

Recent MDR events

2 adverse event reports on file

HEMOSTATIC Y SETSJan 9, 2025
MalfunctionSmiths Healthcare Manufacturing S.a. De C.v.9616567-2025-00006
FOLY CATH 100 SLCON 5CC 16FRMar 22, 2024
MalfunctionCardinal Health1282497-2024-00505

Event type breakdown

Malfunction2

Most-reported manufacturers

Cardinal Health1 Smiths Healthcare Manufacturing S.a. De C.v.1

Recalls

1 recall events for this product code

Aizu Olympus Co., Ltd.
Open, ClassifiedNov 17, 2023
Ureteralscope- for endoscopic
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0347-2024 · View FDA record ↗

Registered firms

0 firms currently registered for this product code

No registered firms found for this product code.

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.