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

Pelvimeter, Internal

21 CFR 884.4530 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

LBX is the FDA product code for Pelvimeter, Internal, a class II device type, regulated under 21 CFR 884.4530. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
LBX
Device name
Pelvimeter, Internal
Regulation
21 CFR 884.4530
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
1
Ingested recalls
0

Clearances, product code LBX

By decision year
1 clearance under product code LBX with a decision year between 1983 and 1983, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LBX by decision year
YearClearances
19831

Applicants with the most clearances

Product code LBX
Applicants holding the most 510(k) clearances under product code LBX
ApplicantClearances
Imm Enterprises, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

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