FDA product code NOY: Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
NOY is the FDA product code for agents, embolic, for treatment of benign prostatic hyperplasia. It is a Class II device, regulated under 21 CFR 876.5550 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 3 510(k) submissions under NOY, from 3 different applicants. The average 510(k) review took 125 days (median 118). 1 De Novo request was granted under it. FDA has posted 1 recall for NOY devices, 1 initiated in the last five years.
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).
Classification
| Field | Value |
|---|---|
| Device name | Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia |
| Device class | Class II |
| Regulation | 21 CFR 876.5550 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NOY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 93 |
| 2020 | 1 | 118 |
| 2021 | 1 | 165 |
Compare with all 510(k) review times · Search every NOY clearance
Top NOY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biocompatibles UK Ltd (Part of Boston Scientific Corporation | 1 | 2021-04-20 |
| MicroVention, Inc. | 1 | 2020-01-22 |
| Boston Scientific | 1 | 2018-04-19 |
Most recent NOY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K203276 | Biocompatibles UK Ltd (Part of Boston Scientific Corporation | Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml) | 2021-04-20 | 165 |
| K192684 | MicroVention, Inc. | HydroPearl Microspheres | 2020-01-22 | 118 |
| K180102 | Boston Scientific | Embozene Color-Advanced Microspheres | 2018-04-19 | 93 |
Recalls for NOY devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-12-21.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code NOY?
NOY is the FDA product code for agents, embolic, for treatment of benign prostatic hyperplasia. It is a Class II device, regulated under 21 CFR 876.5550 and reviewed by the Gastroenterology and Urology panel.
What device class is NOY?
Class II, regulation 21 CFR 876.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code NOY?
Across 3 cleared submissions the average was 125 days from receipt to decision (median 118).
Which companies have the most NOY clearances?
Biocompatibles UK Ltd (Part of Boston Scientific Corporation (1); MicroVention, Inc. (1); Boston Scientific (1).
Have NOY devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2023-12-21.
Next steps
- Run an FDA pathway report with predicate devices for product code NOY
- Run a recall and safety report across every NOY manufacturer
- Watch product code NOY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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