510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203276Substantially Equivalent

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)

Biocompatibles UK Ltd (Part of Boston Scientific Corporation, Farnham, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203276 is the FDA 510(k) clearance record for 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), a class II device, cleared for Biocompatibles UK Ltd (Part of Boston Scientific Corporation on under FDA product code NOY (Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia). FDA's definition for product code NOY 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)". FDA records list one 510(k) clearance for Biocompatibles UK Ltd (Part of Boston Scientific Corporation. As of , FDA records show no recalls naming K203276.

Clearance record

Decision date
Received
(165 days to decision)
Product code
NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Regulation
21 CFR 876.5550
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Biocompatibles UK Ltd (Part of Boston Scientific Corporation Chapman House, Weydon Ln., Farnham, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NOY

Trailing 12 months

FDA records hold no clearances under product code NOY in the trailing twelve months.

FDA records show no clearances under product code NOY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NOY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260