Product code LRT— General Hospital

CROSS-CHECKS

Classification name
Indicator, Sterilization
Device class
Class 2
Regulation
21 CFR 880.2800
Advisory panel
General Hospital
Total cleared
5
First cleared
Most recent

Market context for product code LRT

FDA has cleared 5 devices under product code LRT between 1987 and 2001, filed by 4 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 LRT

Recent clearances under product code LRT

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