Product code EPE— Anesthesiology

TRACHEOSTOMY CLEANSING SOLUTION

Classification name: Brush, Cleaning, Tracheal Tube
Device class: Class 1
Regulation: 21 CFR 868.5795
Advisory panel: Anesthesiology
Total cleared: 2
First cleared: 1986-07-15
Most recent: 1986-11-03

Market context for product code EPE

FDA has cleared 2 devices under product code EPE, all in 1986, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code EPE

Clinipad Corp.1 clearance
Biological & Environmental Control Laboratories1 clearance

Recent clearances under product code EPE

K863635 — UPDATED STERILE ENDOTRACHEAL BRUSHESBiological & Environmental Control Laboratories·1986-11-03
K862563 — TRACHEOSTOMY CLEANSING SOLUTIONClinipad Corp.·1986-07-15

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