DeviceClearance

Product code FHX— Gastroenterology, Urology

BUTTON LUBRICATOR

Classification name
Jelly, Lubricating, For Transurethral Surgical Instrument
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
6
First cleared
Most recent

Market context for product code FHX

FDA has cleared 6 devices under product code FHX between 1977 and 2008, filed by 6 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 FHX

Recent clearances under product code FHX

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