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Institut Georges Lopez: FDA-registered device maker in ST LAURENT DE CHAMOUSSET Rhone, France, 3 510(k) clearances

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

Institut Georges Lopez is registered with the FDA (registration 3024820181) in ST LAURENT DE CHAMOUSSET Rhone, France. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 14, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3024820181
Address: 6 Route De Saint Bonnet, ST LAURENT DE CHAMOUSSET Rhone, France, 69930
Owner or operator: Institut Georges Lopez (10051357)
Roles: Manufacturer
First device listed: March 7, 2016
Registered through: 2026
Brand names listed: BEL-GEN Cold Storage Solution, Celsior Cold Flushing, Storage and Transportation Solution for Hearts, PERF-GEN Pulsatile Perfusion Solution, Waters IGL Cold Storage Solution, Waters IGL Pulsatile Perfusion Solution

Devices it lists

Device	Product code	Class	Role	Source
Set, Perfusion, Kidney, Disposable	KDL	2	Manufacturer	accessdata.fda.gov
System And Accessories, Isolated Heart, Transport And Preservation	MSB	2	Manufacturer	accessdata.fda.gov
System, Perfusion, Kidney	KDN	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
June 14, 2022	K221387	BEL-GEN Cold Storage Solution	KDL	Substantially Equivalent	Institut Georges Lopez	accessdata.fda.gov
June 14, 2022	K221386	PERF-GEN Pulsatile Perfusion Solution	KDL	Substantially Equivalent	Institut Georges Lopez	accessdata.fda.gov
August 5, 1999	K991594	CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS	MSB	Substantially Equivalent	Sangstat Medical Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 13, 2025	96793	Class II	Ongoing	Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical device. Celsior is a clear to slightly yellow, s	The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.	accessdata.fda.gov

Compare with other makers

Updated July 30, 2025. 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.