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

Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

21 CFR 876.5550 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NOY is the FDA product code for Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia, a class II device type, regulated under 21 CFR 876.5550. FDA's definition for this code reads: "The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH)". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NOY
Device name
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
FDA definition
The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).
Regulation
21 CFR 876.5550
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
1

Clearances, product code NOY

By decision year
4 clearances under product code NOY with a decision year between 2017 and 2021, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NOY by decision year
YearClearances
20171
20181
20201
20211

Applicants with the most clearances

Product code NOY
Applicants holding the most 510(k) clearances under product code NOY
ApplicantClearances
Biocompatibles UK Ltd (Part of Boston Scientific Corporation1
Biosphere Medical, S.A.1
Boston Scientific Corporation1
Terumo Cardiovascular Systems Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code