Medical Device Manufacturer · US , Charleston , SC

Organ Recovery Systems, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2002

Recent clearances: SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Organ Recovery Systems, Inc. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Mar 11, 2010

SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L

Gastroenterology & Urology · 275d

Cleared Jul 31, 2003

LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)

Gastroenterology & Urology · 457d

Cleared Oct 21, 2002

MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION

Gastroenterology & Urology · 90d

Cleared Jan 25, 2002

KPS-I, THE KIDNEY PERFUSION SOLUTION

Gastroenterology & Urology · 88d