Product code FAX— Gastroenterology, Urology

ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL

Classification name: Bougie, Urological
Device class: Class 1
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Total cleared: 2
First cleared: 1982-11-03
Most recent: 1995-02-07

Market context for product code FAX

FDA has cleared 2 devices under product code FAX between 1982 and 1995, 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.

Clearances per year

19951 clearance
19821 clearance

Top applicants under product code FAX

Parker Laboratories, Inc.1 clearance
KARL STORZ Endoscopy-America, Inc.1 clearance

Recent clearances under product code FAX

K950125 — KARL STORZ BOUGIES AND DILATORSKARL STORZ Endoscopy-America, Inc.·1995-02-07
K822711 — ANTI-MIST, ANTI-FOG EYEGLASS & DENTALParker Laboratories, Inc.·1982-11-03

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