Chrysalis Intelligence · Sponsors · Institut Georges Lopez

Institut Georges Lopez

Lissieu, FR · 3 510(k) clearances · 1 recalls

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Total clearances

3

2021-10-15 → 2022-06-14

Last 12 months

0

Product codes

2

Most recent

2022-06-14

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
KDL	Set, Perfusion, Kidney, Disposable	Class II	Gastroenterology, Urology	2	2022-06-14
KDN	System, Perfusion, Kidney	Class II	Gastroenterology, Urology	1	2021-10-15

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2025-03-13

Date	Severity	Status	Recall #	Product	Code	Reason
2025-03-13	Class II	Ongoing	Z-2220-2025	Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Pr…	—	The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

Filings

All 510(k) clearances (3)

Date	K-number	Device	Code	Class	Specialty
2022-06-14	K221387	BEL-GEN Cold Storage Solution	KDL	Class II	Gastroenterology, Urology
2022-06-14	K221386	PERF-GEN Pulsatile Perfusion Solution	KDL	Class II	Gastroenterology, Urology
2021-10-15	K211224	RM4 Control Unit	KDN	Class II	Gastroenterology, Urology