Atlas FDA

BEL-GEN Cold Storage Solution

FDA 510(k) clearance K221387 · decided 2022-06-14

Clearance details

K-number
K221387
Device name
BEL-GEN Cold Storage Solution
Applicant
Institut Georges Lopez
Decision
Substantially Equivalent
Date received
2022-05-13
Decision date
2022-06-14
Days to decision
32 days
Clearance type
Traditional
Product code
KDL
Device class
2
Regulation number
876.5880
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Lissieu, FR
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Institut Georges Lopez

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
OrganProtex HTK Solution (K241239)Bridge TO Life, Ltd.2025-01-24
PERF-GEN Pulsatile Perfusion Solution (K221386)Institut Georges Lopez2022-06-14
Servator M SALF Solution (K211842)S.A.L.F. Spa2021-12-20
Custodiol HTK Solution (K192408)Dr. Franz Kohler Chemie GmbH2020-04-24
Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags (K170150)S.A.L.F. Spa2017-10-20
PERF-GEN PULSATILE PERFUSION SOLUTION (K121736)Waters Medical Systems, LLC2013-08-16
BEL-GEN COLD STORAGE SOLUTION (K121618)Waters Medical Systems, LLC2013-06-14
SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L (K091656)Organ Recovery Systems, Inc.2010-03-11
CUSTODIOL (K043461)Dr. Franz Kohler Chemie GmbH2005-02-28
CUSTODIOL HTK SOLUTION (K020924)Dr. Franz Kohler Chemie GmbH2003-01-06
GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SET (K955497)Cobe Renal Care, Inc.1997-09-25
VIASPAN (BELZER UW - CSS) (K944866)The Dupont Merck Pharmaceutical Co.1996-04-22

Recalls involving this device

No recalls on record reference this clearance.