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

Dilator, Nasal

21 CFR 874.3900 / Ear, Nose, Throat
FDA source (opens on fda.gov)

LWF is the FDA product code for Dilator, Nasal, a class I device type, regulated under 21 CFR 874.3900. As of , FDA records hold 20 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LWF
Device name
Dilator, Nasal
Regulation
21 CFR 874.3900
Device class
Class I
Review panel
Ear, Nose, Throat
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
20
Ingested recalls
0

Clearances, product code LWF

By decision year
20 clearances under product code LWF with a decision year between 1986 and 2018, 1995 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code LWF by decision year
YearClearances
19861
19871
19881
19911
19931
19956
19964
19971
19981
20041
20121
20181

Applicants with the most clearances

Product code LWF
Applicants holding the most 510(k) clearances under product code LWF
ApplicantClearances
Cns, Inc.3
Acutek Adhesive Specialties, Inc.2
Corbett Lair, Inc.2
Allied Advanced Technologies (Aat)1
American White Cross, Inc.1
Bivona Medical Technologies1
Breathe with Eez Corp.1
Cambridge Assoc.1
Cns, Inc.1
Cpapnea Medical Supply1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 121 companies shown, in name order