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

Cleaner, Ultrasonic, Medical Instrument

21 CFR 880.6150 / General Hospital
FDA source (opens on fda.gov)

FLG is the FDA product code for Cleaner, Ultrasonic, Medical Instrument, a class I device type, regulated under 21 CFR 880.6150. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
FLG
Device name
Cleaner, Ultrasonic, Medical Instrument
Regulation
21 CFR 880.6150
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
19
Ingested recalls
7

Clearances, product code FLG

By decision year
19 clearances under product code FLG with a decision year between 1977 and 1994, 1994 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code FLG by decision year
YearClearances
19771
19841
19866
19871
19891
19949

Applicants with the most clearances

Product code FLG
Applicants holding the most 510(k) clearances under product code FLG
ApplicantClearances
Palmetto Chemical & Supply Co., Inc.4
Calgon Corp.3
Calgon Vestal Div.3
Wassenburg Medical B.V.1
Fisons Corp.1
Keymed, Inc.1
Medical Polymers, Inc.1
Nobelpharma USA, Inc.1
Rapidex of London1
Spelna, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 150 companies shown, in name order