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

Stent, Vaginal

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

KXP is the FDA product code for Stent, Vaginal, a class II device type, regulated under 21 CFR 884.3900. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KXP
Device name
Stent, 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
4
Ingested recalls
0

Clearances, product code KXP

By decision year
4 clearances under product code KXP with a decision year between 1995 and 2020, 1998 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KXP by decision year
YearClearances
19951
19982
20201

Applicants with the most clearances

Product code KXP
Applicants holding the most 510(k) clearances under product code KXP
ApplicantClearances
Bioteque America Inc1
Owen Mumford USA, Inc.1
PMT Corp.1
Silimed, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code