KDMClass II

Sigmoidoscope, Rigid, Non-electrical

Gastroenterology, Urology · 21 CFR 876.1500

MDR events0All time

Recalls1All time

Registered firms1Currently listed

510(k) clearances1All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Adler MicroMed, Inc.
TerminatedUnknown
Sapi Med sterile disposable colorectal anoscopes and proctoscopes.
Due to issue with product sterility. Sterilization service provider had falsified records.
Z-1901-2021 · View FDA record ↗

Registered firms

1 firms currently registered for this product code

Sapi Med S.p.a
ALESSANDRIA, IT

510(k) clearances

1 clearances for this product code

Sapimed S.P.A.Jul 6, 2007
K070915 · SAPIMED DISPOSABLE SIGMOIDOSCOPE