DeviceClearance

Product code FHO— Gastroenterology, Urology

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Classification name
Pneumoperitoneum Needle
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
15
First cleared
Most recent

FDA classification definition

“For establishment of a pneumoperitoneum in abdomen.”

— U.S. Food and Drug Administration, device classification record for product code FHO under 21 CFR 876.1500, via openFDA

Market context for product code FHO

FDA has cleared 15 devices under product code FHO between 1985 and 2017, filed by 14 applicant companies. 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.

Clearances per year

Top applicants under product code FHO

Recent clearances under product code FHO

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