Cleared Traditional

PERF-GEN Pulsatile Perfusion Solution

K221386 · Institut Georges Lopez · Gastroenterology & Urology

Jun 2022

Decision

32d

Days

Class 2

Risk

About This 510(k) Submission

K221386 is an FDA 510(k) clearance for the PERF-GEN Pulsatile Perfusion Solution, a Set, Perfusion, Kidney, Disposable (Class II — Special Controls, product code KDL), submitted by Institut Georges Lopez (Lissieu, FR). The FDA issued a Cleared decision on June 14, 2022, 32 days after receiving the submission on May 13, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5880.

Submission Details

510(k) Number	K221386 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 2022
Decision Date	June 14, 2022
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF