Srs Medical

FDA Filings

This page includes the latest FDA filings for Srs Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	1223851
FEI Number	1000305746
Name	SRS MEDICAL
Owner & Operator	SRS MEDICAL
Contact Address	76 TREBLE COVE RD. BUILDING #3 North Billerica MA 01862 US
Official Correspondent	LEE - BRODY 001-978-6632800-x
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	76 TREBLE COVE RD. BUILDING No. 3 N Billerica, MA 01862 US
Establishment Type	Manufacture Medical Device Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K882295 \| LJH SRS MEDICAL	SRS Irrigation Set	2019-06-27
PMA P060010S011 SRS MEDICAL	THE SPANNER TEMPORARY PROSTATIC STENT	2013-08-28
PMN P060010 \| NZC SRS MEDICAL	The Spanner Temporary Prostatic Stent	2013-05-09
PMN K070907 \| IYO SRS MEDICAL	UroScan	2012-04-18
PMN K070907 \| ITX SRS MEDICAL	UroScan	2012-04-18
PMA P060010S010 SRS MEDICAL	THE SPANNER TEMPORARY PROSTATIC STENT	2011-07-28
PMA P060010S009 SRS MEDICAL	THE SPANNER TEMPORARY PROSTATIC STENT	2011-06-14
PMN K003367 \| HCC SRS MEDICAL	Orion Platinum	2010-07-09
PMA P060010S008 SRS MEDICAL	THE SPANNER TEMPORARY PROSTATIC STENT	2009-12-09
PMA P060010S007 SRS MEDICAL	THE SPANNER TEMPORARY PROSTATIC STENT	2009-06-26
PMA P060010S006 SRS MEDICAL	THE SPANNER TEMPORARY PROSTATIC STENT	2009-05-27
PMA P060010S005 SRS MEDICAL	THE SPANNER TEMPORARY PROSTATIC STENT	2009-05-19
PMA P060010S004 SRS MEDICAL	THE SPANNER TEMPORARY PROSTATIC STENT	2009-04-14
PMA P060010S003 SRS MEDICAL	SPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE	2009-03-10
PMA P060010S002 SRS MEDICAL	THE SPANNER TEMPORARY PROSTATIC STENT	2008-04-25
PMN K063447 \| IKN SRS MEDICAL	Insight Discovery	2008-04-01
PMN K063447 \| HCC SRS MEDICAL	Insight Discovery	2008-04-01
PMN K033452 \| IKN SRS MEDICAL	CWAS	2008-04-01
EXY SRS MEDICAL	EasyFlo	2008-04-01
EXQ SRS MEDICAL	EasyPro	2008-04-01
EXQ SRS MEDICAL	CT3000Plus	2008-04-01
EXQ SRS MEDICAL	CT3000	2008-04-01
PMA P060010S001 SRS MEDICAL	THE SPANNER TEMPORARY PROSTATIC STENT	2008-02-12
PMA P060010 SRS MEDICAL	THE SPANNER TEMPORARY PROSTATIC STENT	2006-12-14
HCC SRS MEDICAL	INSIGHT MILLENNIUM	2003-03-26
HCC SRS MEDICAL	GENESIS SERIES	2003-03-26

Similar & Related FDA Registered Companies

SRS MEDICAL SYSTEMS, INC.
SRS MEDICAL76 Treble Cove Road, #3north Billerica, MA 01862 PMA NumberP060010 Supplement NumberS013 Date Received06/22/2020 Decision Date10/07/2022 Product Code NZC Advisory Committee Gastroenterology/Urology Clinical TrialsNCT02643849 Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092851639	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	HEALTHCARE PRODUCTS	24 CTN
2020073025283	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	HEALTHCARE PRODUCTS	4 PKG
2020072965386	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	HEALTHCARE PRODUCTS	20 BOX
202007253852	Shanghai ,China (Mainland) -> Boston, Massachusetts	CART	57 CTN
2020071553815	London,United Kingdom -> New York/Newark Area, Newark, New Jersey	HEALTHCARE PRODUCTS	4 PKG
201911012861	Shanghai ,China (Mainland) -> Boston, Massachusetts	CART	13 PKG