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

Stopcock, I.V. Set

21 CFR 880.5440 / General Hospital
FDA source (opens on fda.gov)

FMG is the FDA product code for Stopcock, I.V. Set, a class II device type, regulated under 21 CFR 880.5440. As of , FDA records hold 89 510(k) clearances under this code, the most recent dated , and 205 recalls.

Classification record

Product code
FMG
Device name
Stopcock, I.V. Set
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
89
Ingested recalls
207

Clearances, product code FMG

By decision year
89 clearances under product code FMG with a decision year between 1976 and 2025, 1980 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code FMG by decision year
YearClearances
19764
19774
19782
19793
198010
19812
19824
19831
19842
19854
19863
19876
19882
19892
19901
19912
19942
19951
19964
19972
19982
20012
20021
20031
20041
20051
20063
20072
20082
20092
20132
20141
20181
20192
20222
20232
20251

Applicants with the most clearances

Product code FMG
Applicants holding the most 510(k) clearances under product code FMG
ApplicantClearances
Elcam Medical A.C.A.L.8
Abbott Medical6
Tronomed, Inc.5
American Viggo4
Baxter Healthcare Corporation4
Norton Performance Plastics Corp.4
GE Healthcare4
Custom Medical Devices Intl., Inc.3
American Pharmaseal Div. Ahsc2
Churchill Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 61 companies shown, in name order