510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LEYClass II

Set, Oral Administration

21 CFR 876.5980 / Gastroenterology, Urology
FDA source (opens on fda.gov)

LEY is the FDA product code for Set, Oral Administration, a class II device type, regulated under 21 CFR 876.5980. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LEY
Device name
Set, Oral Administration
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code LEY

By decision year
1 clearance under product code LEY with a decision year between 1976 and 1976, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LEY by decision year
YearClearances
19761

Applicants with the most clearances

Product code LEY
Applicants holding the most 510(k) clearances under product code LEY
ApplicantClearances
Cis Radiopharmaceuticals, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LEY.