Product code LEY— Gastroenterology, Urology

SET, ORAL ADMINISTRATION

Classification name: Set, Oral Administration
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Total cleared: 1
First cleared: 1976-09-15
Most recent: 1976-09-15

Market context for product code LEY

FDA has cleared 1 device under product code LEY, all in 1976, filed by 1 applicant company. 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.

Top applicants under product code LEY

Cis Radiopharmaceuticals, Inc.1 clearance

Recent clearances under product code LEY

K760251 — SET, ORAL ADMINISTRATIONCis Radiopharmaceuticals, Inc.·1976-09-15

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