Data / Medical devices / United States / SRS Medical

SRS Medical: FDA-registered device maker in Chelmsford, MA, United States, 2 510(k) clearances and 1 PMA approval

Name: SRS Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

SRS Medical is registered with the FDA (registration 1223851) in Chelmsford, MA, United States. It lists 6 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated December 21, 2021. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1223851
FEI number: 3033428382
Address: 321 Billerica Rd, Chelmsford, MA, United States, 01824
Owner or operator: SRS MEDICAL (9009409)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: March 26, 2003
Registered through: 2027
Brand names listed: CT3000, CT3000Plus, CT3000Pro, CT3000Pro, UroCuff, EasyFlo, EasyPro, EasyPro One, GENESIS SERIES and more

Devices it lists

Device	Product code	Class	Role	Source
Cystometer, Electrical Recording	EXQ	2	Manufacturer, Specification developer	accessdata.fda.gov
Device, Biofeedback	HCC	2	Manufacturer	accessdata.fda.gov
Device, Cystometric, Hydraulic	FEN	2	Manufacturer	accessdata.fda.gov
Electromyograph, Diagnostic	IKN	2	Manufacturer	accessdata.fda.gov
Stent, Urethral, Prostatic, Semi-Permanent	NZC	3	Repackager or relabeler	accessdata.fda.gov
Uroflowmeter	EXY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 21, 2021	K212830	CT3000Pro	FEN	Substantially Equivalent	Srs Medical	accessdata.fda.gov
August 16, 2007	K063447	INSIGHT DISCOVERY	IKN	Substantially Equivalent	Fasstech	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
December 14, 2006	P060010	THE SPANNER TEMPORARY PROSTATIC STENT	NZC	13	October 7, 2022	accessdata.fda.gov

Compare with other makers

Updated October 7, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.