Data / Medical devices / Monaco / Rocamed Sam

Rocamed Sam: FDA-registered device maker in MONACO Monaco-Ville, Monaco, 8 510(k) clearances

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

Rocamed Sam is registered with the FDA (registration 3016096097) in MONACO Monaco-Ville, Monaco. It lists 10 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 17, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3016096097
Address: 9 Avenue Albert II Le copori, MONACO Monaco-Ville, Monaco, 98000
Owner or operator: ROCAMED SAM (10092141)
Roles: Exporter to the US, Manufacturer
First device listed: December 9, 2024
Registered through: 2026
Brand names listed: Bi-Flex Evo, Catheter for irrigation, irrigation line; Endoscopic irrigation line TraxerFlow, double spikes, with flushing pump, univ, ECHOLASER X4, ELESTA S.P.A, ENDOFLOW II - Irrigation, Warming and Suction System, Echolaser Smart Interface, Irrigation/Aspiration set, JFil Ureteral Stents, JFil Ureteral Stents ECO KIT and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter, G-U	KNY	2	Manufacturer	accessdata.fda.gov
Catheter, Irrigation	GBX	1	Manufacturer	accessdata.fda.gov
Catheter, Ureteral, Gastro-Urology	EYB	2	Manufacturer	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Manufacturer	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Manufacturer	accessdata.fda.gov
Needle, Aspiration And Injection, Disposable	GAA	1	Exporter to the US	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Exporter to the US	accessdata.fda.gov
Stent, Ureteral	FAD	2	Manufacturer	accessdata.fda.gov
Stylet, Ureteral	EYA	1	Manufacturer	accessdata.fda.gov
System, Evacuator, Fluid	FHF	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
March 17, 2026	K260632	LASER THERMAL THERAPY KIT	GEX	Substantially Equivalent	Elesta S.P.A	accessdata.fda.gov
May 22, 2023	K230460	Laser Thermal Therapy Kit	GEX	Substantially Equivalent	Elesta S.P.A	accessdata.fda.gov
May 3, 2022	K213594	ECHOLASER X4	GEX	Substantially Equivalent	Elesta S.P.A	accessdata.fda.gov
January 26, 2022	K212868	JFil Ureteral Stents, JFil Ureteral Stents ECO KIT	FAD	Substantially Equivalent	Rocamed Sam	accessdata.fda.gov
April 23, 2020	K192183	RocaTub Ureteral Catheter	EYB	Substantially Equivalent	Promepal Sam	accessdata.fda.gov
September 7, 2018	K182144	Bi-Flex Evo	KNY	Substantially Equivalent	Promepla Sam	accessdata.fda.gov
March 12, 2018	K173734	RocaJJ Soft Stents	FAD	Substantially Equivalent	Promepla Sam	accessdata.fda.gov
February 9, 2016	K152278	ENDOFLOW II - Irrigation, Warming and Suction System	OCX	Substantially Equivalent	Promepla Sam	accessdata.fda.gov

Compare with other makers

Updated March 17, 2026. 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.