Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016096097

FEI Number

3016096097

Entity Name

ROCAMED SAM

City/State/Country

MONACO Monaco-Ville, MC

Establishment Address

9 Avenue Albert II, Le copori, MONACO Monaco-Ville 98000, MC

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ROCAMED SAM (Owner Number: 10092141)

Owner / Operator Contact Address

9 Av Albert II, MONACO, MC-MO 98000, MC

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212868

PMA Number

N/A

All Registered Proprietary Names

Bi-Flex Evo Irrigation/Aspiration set ENDOFLOW II - Irrigation, Warming and Suction System Laser Thermal Therapy Kit Catheter for irrigation, irrigation line; Endoscopic irrigation line TraxerFlow, double spikes, with flushing pump, univ Rocamed RocaWire Guidewires; Roca Wire Rio Tracer Echolaser Smart Interface JFil Ureteral Stents, JFil Ureteral Stents ECO KIT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	Class 2	876.5130	2024-12-09
FHF	System, Evacuator, Fluid	Gastroenterology, Urology	Class 2	876.4370	2024-12-09
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2024-12-09
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2024-12-09
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2024-12-09
EYA	Stylet, Ureteral	Gastroenterology, Urology	Class 1	876.5130	2024-12-09
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2024-12-09
FAD	Stent, Ureteral	Gastroenterology, Urology	Class 2	876.4620	2024-12-09

Official Correspondent

Erica Tartaglione

US Agent Details

Chuck Philipp Email: chuckp@sundance17.net Phone: (720) 3523893

Related Public Records

Same Entity

ROCAMED SAM

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873288	Todd Medical, Inc.	CLOSED FOLEY CATHETER SYSTEM	1987-11-27
K912919	Mentor Corp.	MENTOR INFUSION LINE	1991-12-13
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016096097. Last updated year: 2026. Please use registration number 3016096097 when referencing this establishment in official correspondence.