Embozene Color-Advanced Microspheres

Q: What is the product code of K180102?

The FDA product code is NOY – Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia, a Class II (moderate risk) device regulated under 21 CFR 876.5550.

FDA 510(k) K180102 · Boston Scientific

Substantially Equivalent

510(k) numberK180102

Submission

Device name: Embozene Color-Advanced Microspheres
Applicant: Boston Scientific
Maple Grove, MN, US
Received: January 16, 2018
Decision date: April 19, 2018
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NOY – Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Device class: Class II (moderate risk)
Regulation: 21 CFR 876.5550
Specialty: Gastroenterology, Urology
Implant: Yes

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).

Other 510(k)s with product code NOY

510(k)	Device	Applicant	Decision
K203276	Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm…NOY · Traditional	Biocompatibles UK Ltd (Part of Boston Scientific…	04/20/2021SE
K192684	HydroPearl MicrospheresNOY · Traditional	MicroVention, Inc.	01/22/2020SE

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Questions and answers

When was Embozene Color-Advanced Microspheres cleared by the FDA?

Embozene Color-Advanced Microspheres (K180102) received a 510(k) decision of Substantially Equivalent on April 19, 2018, 93 days after the submission was received.

What is the product code of K180102?

The FDA product code is NOY – Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia, a Class II (moderate risk) device regulated under 21 CFR 876.5550.