DeviceClearance

Product code KDM— Gastroenterology, Urology

SAPIMED DISPOSABLE SIGMOIDOSCOPE

Classification name
Sigmoidoscope, Rigid, Non-Electrical
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
1
First cleared
Most recent

Market context for product code KDM

FDA has cleared 1 device under product code KDM, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code KDM

Recent clearances under product code KDM

Data sourced from openFDA. This site is unofficial and independent of the FDA.