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)

FDA 510(k) clearance K203276 · decided 2021-04-20

Clearance details

K-number: K203276
Device name: 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)
Applicant: Biocompatibles UK Ltd (Part of Boston Scientific Corporation
Decision: Substantially Equivalent
Date received: 2020-11-06
Decision date: 2021-04-20
Days to decision: 165 days
Clearance type: Traditional
Product code: NOY
Device class: 2
Regulation number: 876.5550
Medical specialty: Gastroenterology, Urology
Advisory committee: Gastroenterology, Urology
Location: Farnham, GB
Third-party review: No
Expedited review: No

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Devices cleared under the same product code - the starting set for predicate research.

Record	Firm	Date
HydroPearl Microspheres (K192684)	MicroVention, Inc.	2020-01-22
Embozene Color-Advanced Microspheres (K180102)	Boston Scientific	2018-04-19
Embosphere Microspheres (DEN160040)	Biosphere Medical, S.A.	2017-06-21

No recalls on record reference this clearance.