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

Dilator, Vaginal

21 CFR 884.3900 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HDX is the FDA product code for Dilator, Vaginal, a class II device type, regulated under 21 CFR 884.3900. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HDX
Device name
Dilator, Vaginal
Regulation
21 CFR 884.3900
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
9
Ingested recalls
1

Clearances, product code HDX

By decision year
9 clearances under product code HDX with a decision year between 2001 and 2024, 2023 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HDX by decision year
YearClearances
20011
20091
20131
20211
20233
20242

Applicants with the most clearances

Product code HDX
Applicants holding the most 510(k) clearances under product code HDX
ApplicantClearances
Lujena, Inc.2
Materna Medical2
Plus EV Holdings dba Intimate Rose2
Bioteque America Inc1
Karl Storz Endoscopy-America, Inc.1
Panpac Medical Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order