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

Laser, Ent Microsurgical Carbon-Dioxide

21 CFR 874.4500 / Ear, Nose, Throat
FDA source (opens on fda.gov)

EWG is the FDA product code for Laser, Ent Microsurgical Carbon-Dioxide, a class II device type, regulated under 21 CFR 874.4500. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EWG
Device name
Laser, Ent Microsurgical Carbon-Dioxide
Regulation
21 CFR 874.4500
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
24
Ingested recalls
0

Clearances, product code EWG

By decision year
24 clearances under product code EWG with a decision year between 1980 and 1993, 1986 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code EWG by decision year
YearClearances
19802
19811
19821
19842
19851
19867
19875
19884
19931

Applicants with the most clearances

Product code EWG
Applicants holding the most 510(k) clearances under product code EWG
ApplicantClearances
Directed Energy, Inc.5
Cooper Lasersonics, Inc.3
Britt Corp., Inc.2
Endo Lase, Inc.2
Laserscope2
Minnesota Laser Corp.2
American Surgical Laser, Inc.1
Benson Medical Instruments Co.1
Lasermatic, Inc.1
Lumenis Ltd1

Companies listing this code with FDA

Companies whose registered establishments list this code

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