Product code KCF— Ear, Nose, Throat

MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE

Classification name: Dilator, Esophageal, Ent
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Total cleared: 3
First cleared: 1981-09-08
Most recent: 1996-07-25

Market context for product code KCF

FDA has cleared 3 devices under product code KCF between 1981 and 1996, filed by 1 applicant company. 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

19961 clearance
19921 clearance
19811 clearance

Top applicants under product code KCF

Boston Medical Products, Inc.3 clearances

Recent clearances under product code KCF

K962688 — MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBEBoston Medical Products, Inc.·1996-07-25
K923355 — PHARYNGEAL SALIVARY BYPASS TUBEBoston Medical Products, Inc.·1992-10-06
K812305 — MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBEBoston Medical Products, Inc.·1981-09-08

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