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

Tube, Levine

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

FRQ is the FDA product code for Tube, Levine, a class II device type, regulated under 21 CFR 876.5980. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FRQ
Device name
Tube, Levine
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
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code FRQ

By decision year
3 clearances under product code FRQ with a decision year between 1980 and 1992, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FRQ by decision year
YearClearances
19801
19911
19921

Applicants with the most clearances

Product code FRQ
Applicants holding the most 510(k) clearances under product code FRQ
ApplicantClearances
Icn Pharmaceuticals, Inc.1
Mallinckrodt Medical1
Pollak (Intl.).ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code