510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KDMClass II

Sigmoidoscope, Rigid, Non-Electrical

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

KDM is the FDA product code for Sigmoidoscope, Rigid, Non-Electrical, a class II device type, regulated under 21 CFR 876.1500. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
KDM
Device name
Sigmoidoscope, Rigid, Non-Electrical
Regulation
21 CFR 876.1500
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
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code KDM

By decision year
1 clearance under product code KDM with a decision year between 2007 and 2007, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KDM by decision year
YearClearances
20071

Applicants with the most clearances

Product code KDM
Applicants holding the most 510(k) clearances under product code KDM
ApplicantClearances
Sapimed S.p.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code