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

Sound, Urethral, Metal Or Plastic

21 CFR 876.5520 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FBX is the FDA product code for Sound, Urethral, Metal Or Plastic, a class I device type, regulated under 21 CFR 876.5520. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
FBX
Device name
Sound, Urethral, Metal Or Plastic
Regulation
21 CFR 876.5520
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code FBX

By decision year
1 clearance under product code FBX with a decision year between 1995 and 1995, 1995 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FBX by decision year
YearClearances
19951

Applicants with the most clearances

Product code FBX
Applicants holding the most 510(k) clearances under product code FBX
ApplicantClearances
Candela Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order