FDA 510(k) Application Details - K241209

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K241209
Device Name	Kit, Needle, Biopsy
Applicant	Cook Ireland Ltd. O'Halloran Road National Technology Park, Plassey Limerick V94 N8X2 IE Other 510(k) Applications for this Company
Contact	Brian O'Mara Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2024
Decision Date	07/29/2024
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