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Koelis: FDA-registered device maker in MEYLAN Isere, France, 4 510(k) clearances

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

Koelis is registered with the FDA (registration 3008487708) in MEYLAN Isere, France. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 10, 2018. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008487708
Address: 22 Chemin Du Vieux Chene, MEYLAN Isere, France, 38240
Owner or operator: KOELIS (10033933)
Roles: Manufacturer
First device listed: December 23, 2014
Registered through: 2027
Brand names listed: Disposable Guide, REUSABLE GUIDE, Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range, TRINITY/3D PROSTATE SUITE

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	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
July 10, 2018	K180970	Disposable guides KDNG00	ITX	Substantially Equivalent	Koelis	accessdata.fda.gov
July 31, 2017	K171040	Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range	ITX	Substantially Equivalent	Koelis	accessdata.fda.gov
May 30, 2017	K170521	TRINITY/3D PROSTATE SUITE	IYN	Substantially Equivalent	Koelis	accessdata.fda.gov
July 11, 2014	K141334	REUSABLE GUIDE	ITX	Substantially Equivalent	Koelis	accessdata.fda.gov

Compare with other makers

Updated July 10, 2018. 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.