FDA 510(k) Application Details - K203276

Device Classification Name	More FDA Info for this Device
510(K) Number	K203276
Device Name	Bead Block (100 - 300╡m, 1ml), Bead Block (300 - 500╡m, 1ml), Bead Block (500 - 700╡m, 1ml), Bead Block (700 - 900╡m, 1ml), Bead Block (900 - 1200╡m, 1ml), Bead Block (100 - 300╡m, 2ml), Bead Block (300 - 500╡m, 2ml), Bead Block (500 - 700╡m, 2ml), Bead B
Applicant	Biocompatibles UK Ltd (part of Boston Scientific Corporation Chapman House, Weydon Lane Farnham GU9 8QL GB Other 510(k) Applications for this Company
Contact	Christina Fischer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	NOY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2020
Decision Date	04/20/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review