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)— 510(k) K203276

Name: FDA 510(k) clearance K203276
Creator: U.S. Food and Drug Administration
Published: 2021-04-20

Substantially Equivalent

Biocompatibles UK Ltd (Part of Boston Scientific Corporation

FDA 510(k) clearance K203276 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), Substantially Equivalent on 2021-04-20. Applicant: Biocompatibles UK Ltd (Part of Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Biocompatibles UK Ltd (Part of Boston Scientific Corporation
Product code: Code NOY
Device class: Class 2
Regulation: 21 CFR 876.5550
Advisory panel: Gastroenterology, Urology
Date received: 2020-11-06
Decision date: 2021-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farnham, GB

Download summary PDF View on FDA.gov ↗

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