SRS MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1223851	3033428382	SRS MEDICAL	1	Y	2026-01-01	321 Billerica Rd Chelmsford MA US 01824

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
48274	1572868999	P060010	THE SPANNER TEMPORARY PROSTATIC STENT	NZC	2006-12-14
48274	1807326717	K882295	FILLING VOLUME OPTION	LJH	1988-09-13
48274	1999214997	K881878	CATHETER WITHDRAWAL UNIT	KNY	1988-07-28
48274	1362732561	K850169	ERIS URO-DIAGNOSTIC SYSTEM	FFG	1985-04-22
48274	1485156477	K212830	CT3000Pro	FEN	2021-12-21
48274	1665389269	K070907	INTERSON USB ULTRASOUND PROBE SYSTEM	IYO	2007-04-17
48274	1197599472	K063447	INSIGHT DISCOVERY	IKN	2007-08-16
48274	1906246307	K033452	CWAS 1000	IKN	2003-11-28
48274	1719561346	K003367	ORION PLATINUM	HCC	2001-01-04
48274	1017264040
48274	1308110448
48274	1702911397
48274	2040664356

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
IKN	2	2007-08-16
FEN	1	2021-12-21
IYO	1	2007-04-17
NZC	1	2006-12-14
HCC	1	2001-01-04
LJH	1	1988-09-13
KNY	1	1988-07-28
FFG	1	1985-04-22

PMA#

The Spanner Temporary Prostatic Stent
2022-10-07
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...
THE SPANNER TEMPORARY PROSTATIC STENT
2013-08-28
SRS MEDICAL
THE SPANNER TEMPORARY PROSTATIC STENT
2011-07-28
SRS MEDICAL
THE SPANNER TEMPORARY PROSTATIC STENT
2011-06-14
SRS MEDICAL
THE SPANNER TEMPORARY PROSTATIC STENT
2009-12-09
SRS MEDICAL
THE SPANNER TEMPORARY PROSTATIC STENT
2009-06-26
SRS MEDICAL
THE SPANNER TEMPORARY PROSTATIC STENT
2009-05-27
SRS MEDICAL
THE SPANNER TEMPORARY PROSTATIC STENT
2009-05-19
SRS MEDICAL
THE SPANNER TEMPORARY PROSTATIC STENT
2009-04-14
SRS MEDICAL
SPANNER TEMPORARY PROSTATIC STENT WITH DISTAL CURVE DESIGN CHANGE
2009-03-10
SRS MEDICAL
THE SPANNER TEMPORARY PROSTATIC STENT
2008-04-25
SRS MEDICAL
THE SPANNER TEMPORARY PROSTATIC STENT
2008-02-12
SRS MEDICAL
THE SPANNER TEMPORARY PROSTATIC STENT
2006-12-14
SRS MEDICAL

PMN#

CT3000Pro
2021-12-21
Srs Medical
ORION PLATINUM
2001-01-04
SRS MEDICAL SYSTEMS, INC.
REGAIN DESKTOP
2001-01-04
SRS MEDICAL SYSTEMS, INC.
SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ANAL EMG/STIMULATION PERINEOMETER SENSOR
2000-11-29
SRS MEDICAL SYSTEMS, INC.

GUDID#

Tri-Electrode Surface EMG - 730-003
SRS Medical Systems, Inc.
2026-03-04
Tri-Electrode Surface EMG - 730-003
SRS Medical Systems, Inc.
2026-03-04
EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) - 35700015S
SRS Medical Systems, Inc.
2026-01-21
EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) - 35700015S
SRS Medical Systems, Inc.
2026-01-21
EasyFlo Console - 900-044
SRS Medical Systems, Inc.
2023-04-26
CT3000 Pro Base Unit - 900-040
SRS Medical Systems, Inc.
2020-09-29
Insight Discovery EMG - 900-037
SRS Medical Systems, Inc.
2021-08-19
Insight Discovery Thermal (w/cable) - 900-014-2
SRS Medical Systems, Inc.
2021-08-20
EMG Sensor - 900-026
SRS Medical Systems, Inc.
2021-08-20
Insight Discovery PWP (w/cable) - 900-023
SRS Medical Systems, Inc.
2021-08-20
Insight Discovery Algometer - 900-015-2
SRS Medical Systems, Inc.
2021-08-20
Insight Discovery Dual Inclinometer - 900-024-2
SRS Medical Systems, Inc.
2021-08-20
Insight Discovery PWP - 900-036
SRS Medical Systems, Inc.
2021-08-20
Insight Discovery Thermal - 900-034
SRS Medical Systems, Inc.
2021-08-20
Discovery Base Unit - 900-010
SRS Medical Systems, Inc.
2018-06-25
UDS Pump - 21385
SRS Medical Systems, Inc.
2021-08-20
CT3000 Scale - CT3-02
SRS Medical Systems, Inc.
2021-08-19
Uroflow Scale - 900-035
SRS Medical Systems, Inc.
2021-08-19
CT3000 Base Unit - 900-027
SRS Medical Systems, Inc.
2021-08-19
UroFlow Scale - 900-042
SRS Medical Systems, Inc.
2021-08-17
UroCuff-DC Disposable, Single - 730-002
SRS Medical Systems, Inc.
2020-09-29
UroCuff-DC Disposable, Single - 730-002
SRS Medical Systems, Inc.
2020-09-29
Leak Pnt Det, Single - LPD-3D
SRS Medical Systems, Inc.
2018-12-24
EMG Elect. w/Lead Wire Set, EP (1 set of 3/bag) - 35700015S
SRS Medical Systems, Inc.
2018-12-24
EP1 VP Test Pressure Kit, Single - 730-001
SRS Medical Systems, Inc.
2018-10-30
EasyPro One - 900-038
SRS Medical Systems, Inc.
2018-06-25
EasyFlo Base Unit - 84411314
SRS Medical Systems, Inc.
2018-06-25
EasyFlo Scale - 84411318
SRS Medical Systems, Inc.
2018-06-25
CT3000Plus Base Unit - 900-031
SRS Medical Systems, Inc.
2018-06-25
EasyPro 4.1 Base Unit - 900-032
SRS Medical Systems, Inc.
2018-06-25
Surveyor Urethral Measurement Device - Surveyor
SRS Medical Systems, Inc.
2014-09-01
The Spanner Temporary Prostatic Stent - The Spanner Stent Size 9
SRS Medical Systems, Inc.
2014-09-01
The Spanner Temporary Prostatic Stent - The Spanner Stent Size 8
SRS Medical Systems, Inc.
2014-09-01
The Spanner Temporary Prostatic Stent - The Spanner Stent Size 7
SRS Medical Systems, Inc.
2014-09-01
The Spanner Temporary Prostatic Stent - The Spanner Stent Size 6
SRS Medical Systems, Inc.
2014-09-01
The Spanner Temporary Prostatic Stent - The Spanner Stent Size 5
SRS Medical Systems, Inc.
2014-09-01
The Spanner Temporary Prostatic Stent - The Spanner Stent Size 4
SRS Medical Systems, Inc.
2014-09-01