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

Prosthesis, Larynx (Stents And Keels)

21 CFR 874.3620 / Ear, Nose, Throat
FDA source (opens on fda.gov)

FWN is the FDA product code for Prosthesis, Larynx (Stents And Keels), a class II device type, regulated under 21 CFR 874.3620. As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FWN
Device name
Prosthesis, Larynx (Stents And Keels)
Regulation
21 CFR 874.3620
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
No
Ingested clearances
10
Ingested recalls
1

Clearances, product code FWN

By decision year
10 clearances under product code FWN with a decision year between 1984 and 2009, 1984 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FWN by decision year
YearClearances
19843
19861
19871
19891
19901
19961
20001
20091

Applicants with the most clearances

Product code FWN
Applicants holding the most 510(k) clearances under product code FWN
ApplicantClearances
Boston Medical Products, Inc.4
Hood Laboratories2
E. Benson Hood Lab, Inc.1
E. Benson Hood Laboratories, Inc.1
Exmoor Plastics Limited1
Biomet Microfixation1

Companies listing this code with FDA

Companies whose registered establishments list this code